CLASS II Device recall · Reported 4 Dec 2019 · FDA Enforcement Report

UniCel DxH Slidemaker Stainer (DxH SMS) recalled by Beckman Coulter

Beckman Coulter is recalling UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II), distributed nationwide in the US. The recall was initiated on 7 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number 775222. Serial numbers: AS39017, AS40018, AT35013, AT35014, AT35015, AT35017, AT35018, AT40020, AT40021, AT40022, AT40024, AT40025, AT40027, AT40030, AT45031, AT45032, AT45034, AT45035, AT49037, AT49041, AT49044, AT49045, AT49046, AT49047, AT49048, AT49049, AT49050, AT49051, AT49055, AT49057, AT49058, AT49059, AT49060, AT49061, AT49062, AT49063, AT49064, AT49065, AU01004, AU01005, AU01007, AU01009, AU01010, AU01011, AU01012, AU01014, AU01015, AU01016, AU01017, AU01020, AU01021, AU01022, AU01023, AU01024, AU01025, AU01028, AU01029, AU01030, AU08041, AU08043, AU08044, AU08047, AU08048, AU08049, AU08050, AU11051, AU11053, AU11057, AU11058, AU11059, AU11061, AU11062, AU11063, AU11064, AU11066, AU11068, AU11072, AU13073, AU13075, AU13077, AU13079, AU14083, AU14084, AU14085, AU14086, AU14087, AU14088, AU14090, AU16104, AU16111, AU16112, AU19113, AU19115, AU19118, AU19119, AU19120, AU20123, AU20124, AU20125, AU20128, AU20129, AU20130, AU20131, AU21133, AU21136, AU21137, AU21141, AU23146, AU23147, AU23149, AU23150, AU23151, AU23152, AU28153, AU28154, AU28160, AU28161, AU29163, AU29165, AU29167, AU29168, AU29169, AU29172, AU30173, AU30178, AU30180, AU30181, AU30182, AU35183, AU35185, AU35186, AU35187, AU35188, AU36189, AU36192, AU36193, AU36196, AU36198, AU36200, AU36201, AU36202, AU36203, AU36204, AU40205, AU40207, AU40209, AU40210, AU40211, AU40213, AU40214, AU40215, AU40216, AU40217, AU40218, AU40221, AU43223, AU43225, AU43226, AU43228, AU43229, AU43231, AU43232, AU43233, AU43234, AU43235, AU43237, AU43240, AU49254, AU49256, AU49259, AV01003, AV01004, AV01005, AV01007, AV01009, AV01010, AV01011, AV01012, AV01013, AV01014, AV01016, AV06018, AV06020, AV06023, AV06026, AV06028, AV06030, AV10033, AV10034, AV10035, AV10036, AV10038, AV10039, AV10042, AV10044, AV10045, AV12047, AV12049, AV12054, AV12055, AV12056, AV14057, AV14059, AV14061, AV14062, AV14063, AV16072, AV16073, AV16075, AV16077, AV16078, AV16080, AV16082, AV16083, AV16086, AV16088, AV16089, AV16090, AV16091, AV21092, AV21093, AV21095, AV21096, AV22097, AV22100, AV22102, AV22105, AV22106, AV23107, AV23109, AV23110, AV23111, AV23112, AV23113, AV23116, AV27117, AV27118, AV27120, AV27121, AV36127, AV36128, AV36129, AV36130, AV39131, AV39132, AV39133, AV39134, AV39135, AV40136, AV40137, AV40139, AV40140, AV40143, AV40145, AV42147, AV42149, AV42150, AV42151, AV42152, AV42153, AV42154, AV42155, AV44156, AV44157, AV44158, AV44160, AV44161, AV44162, AV44163, AV44164, AV47167, AV47168, AV47169, AV47170, AV48171, AV48173, AV48174, AV48176, AV48177, AV48178, AV48179, AV49181, AV49183, AV49184, AV49185, AV49187, AV49188, AV49189, AV51191, AV51192, AW01001, AW01002, AW01007, AW01008, AW01010, AW01011, AW01012, AW01013, AW01014, AW01015, AW06016, AW06018, AW06019, AW06020, AW06021, AW06023, AW06024, AW06025, AW06026, AW06027, AW06028, AW06029, AW09031, AW09032, AW09033, AW09034, AW09035, AW10036, AW10037, AW10038, AW10039, AW10040, AW10041, AW10044, AW10045, AW14046, AW14048, AW14049, AW14051, AW16052, AW16053, AW16054, AW16056, AW16057, AW16058, AW16059, AW16060, AW16061, AW20062, AW20063, AW20064, AW20065, AW20066, AW20067, AW20068, AW20069, AW20070, AW20071, AW23072, AW23073, AW23074, AW23075, AW23076, AW23077, AW23078, AW23079, AW28087, AW28088, AW28089, AW28090, AW28091, AW28094, AW28095, AW28096, AW28097, AW28098, AW31099, AW31100, AW31102, AW31103, AW31104, AW31105, AW31106, AW31107, AW31108, AW31109, AW31110, AW35111, AW35112, AW35113, AW35114, AW35115, AW35116, AW35117, AW35120, AW35121, AW35122, AW35123, AW35124, AW35125, AW35126, AW35127, AW35128, AW42129, AW42131, AW42132, AW42133, AW45134, AW45135, AW45136, AW45137, AW45138, AW45139, AW45140, AW45141, AW45143, AW45144, AW45145, AW45146, AW45147, AW47148, AW47149, AW47151, AW47152, AW47153, AW47154, AW47155, AW47156, AW47157, AW49159, AW49160, AW49161, AW49162, AW49163, AW49164, AW49165, AY01001, AY01002, AY01004, AY01005, AY01006, AY01007, AY01008, AY01009, AY01010, AY04011, AY04012, AY04013, AY04015, AY04016, AY04017, AY04018, AY04019, AY04020, AY08021, AY08022, AY08023, AY08024, AY08025, AY08026, AY08027, AY08028, AY08029, AY08032, AY08033, AY08034, AY10036, AY10037, AY10038, AY10039, AY10040, AY10041, AY10042, AY10044, AY10045, AY10046, AY10047, AY10048, AY10049, AY10051, AY10053, AY10054, AY10055, AY17056, AY17057, AY17058, AY17059, AY17060, AY17061, AY17062, AY17063, AY17064, AY17065, AY19066, AY19067, AY19069, AY19070, AY19071, AY19072, AY19073, AY19074, AY19075, AY23076, AY23077, AY23078, AY23079, AY23080, AY23081, AY30085, AY30086, AY30087, AY30088, AY30090, AY32092, AY32093, AY32094, AY32095, AY32096, AY32097, AY32098, AY32099, AY32100, AY32101, AY32102, AY32103, AY32104, AY32105, AY32106, AY35107, AY35108, AY35109, AY35110, AY35111, AY35112, AY35113, AY35114, AY35115, AY35116, AY35117, AY35118, AY35119, AY35120, AY35121, AY40123, AY40124, AY40125, AY40126, AY41127, AY41128, AY41129, AY41130, AY41132, AY41133, AY41134, AY41140, AY41141, AY51142, AY51143, AY51144, AY51145, AY51149, AY52150, AY52151, AY52152, AY52153, AY52154, AY52155, AY52156, AY52157, AY52158, AY52159, AZ02001, AZ02002, AZ02004, AZ02006, AZ02007, AZ02008, AZ02009, AZ02010, AZ06011, AZ06012, AZ06013, AZ06014, AZ06015, AZ06016, AZ06017, AZ06018, AZ06020, AZ06021, AZ06022, AZ08023, AZ08024, AZ08025, AZ08026, AZ08027, AZ08028, AZ08029, AZ08030, AZ08031, AZ12033, AZ12034, AZ12035, AZ12038, AZ12040, AZ12042, AZ12043, AZ12044, AZ17045, AZ17046, AZ17048, AZ17050, AZ17051, AZ17053, AZ18054, AZ18055, AZ18056, AZ18057, AZ19058, AZ19059, AZ19060, AZ19061, AZ20062, AZ20063, AZ20064, AZ20065, AZ20066, AZ20067, AZ20068, AZ20069, AZ20070, AZ22071, AZ22072, AZ22073, AZ22074, AZ22075, AZ23077, AZ23078, AZ23079, AZ23080, AZ24081, AZ24082, AZ24083, AZ24084, AZ24085, AZ25087, AZ25088, AZ25089, AZ25090, AZ28091, AZ28092, AZ28093, AZ28094, AZ28095, AZ28096, AZ28097, AZ28098, AZ28099, AZ28100, AZ34101, AZ34102, AZ34103, AZ34104, AZ34105, AZ34106, AZ34107, AZ34108, AZ34109, AZ34110, AZ34111, AZ34112, AZ34113, AZ34114, AZ34115, AZ39116, AZ39118, AZ39119, AZ39120, AZ39121, AZ39122, AZ39123, AZ39124, AZ39125, AZ41127, AZ41131, AZ41132, AZ41133, AZ41134, AZ41135, AZ43136, AZ43137, AZ43138, AZ43139, AZ43140, AZ43141, AZ43143, AZ46146, AZ46147, AZ46148, AZ46149, AZ46150, AZ46151, AZ46152, AZ46156, AZ46157, AZ46158, AZ46159, AZ48160, AZ48162, AZ48163, AZ48164, AZ48166, AZ48167, AZ49168, AZ49169, AZ49170, AZ49172, AZ49173, AZ49174, AZ49175, AZ49176, BA03001, BA03002, BA03003, BA03004, BA03005, BA03006, BA03007, BA03008, BA03009, BA03010, BA07011, BA07012, BA07013, BA07014, BA07015, BA07016, BA07017, BA07018, BA07019, BA07020, BA08021, BA08022, BA08023, BA08024, BA08025, BA10026, BA10027, BA10028, BA10029, BA10030, BA10031, BA13032, BA13034, BA13035, BA13036, BA13037, BA13038, BA13039, BA13040, BA13041, BA15042, BA15045, BA16047, BA16048, BA16049, BA16050, BA17052, BA17053, BA17054, BA18055, BA18056, BA18057, BA19060, BA19061, BA19062, BA21064, BA22067, BA22068, BA22069, BA22070, BA23071, BA23072, BA23073, BA24075, BA24076, BA24077, BA24078, BA25080, BA25081, BA25082, BA25083, BA25084, BA25085, BA27086, BA27087, BA27088, BA27089, BA27090, BA29091, BA29092, BA29093, BA29094, BA29095, BA31096, BA31097, BA31098, BA31099, BA31100, BA35101, BA35103, BA35104, BA35105, BA36106, BA36107, BA37109, BA37110, BA37111, BA37112, BA38113, BA38114, BA38115, BA40116, BA40117, BA40118, BA41119, BA41120, BA41121, BA41122, BA43124, BA43126, BA46127, BA46128, BA46129, BA46130, BA48131, BA48132, BA48133, BA49134, BA49135, BA49136, BA49137, BA50138, BA50139, BA50140, BA50141, BA50142, BB03001, BB03002, BB03003, BB03004, BB04005, BB04006, BB05007, BB05008, BB05009, BB06010, BB09011, BB09012, BB09013, BB09014, BB09015, BB16016, BB16017, BB16018, BB16019, BB16021, BB16022, BB16023, BB23024, BB23025, BB23026, BB23027, BB23028, BB27029, BB27030, BB27031, BB27032, BB27033, BB27034, BB47045, BB47046, BB47047, BB47048, BB47049, BB47050, BB47051, BB47052, BB47053, BB47054, BC01001, BC01002, BC01003, BC01004, BC04006, BC04007, BC04008, BC10016, BC10017, BC10018, BC10019, BC14021, BC14022, BC14023, BC14024, BC21026, BC21027, BC29030, BC29031, BC29032, BC29035, BC30036, BC30039. Catalog Number B66705. Serial Numbers: AZ30002, AZ30003, AZ30004, AZ39005, BA14002. Catalog Number C11477. Serial Numbers: BB11109, BB11110, BB12111, BB12117, BB12118, BB12119, BB12120, BB12121, BB12122, BB12123, BB18124, BB18125, BB18126, BB18127, BB18128, BB18129, BB18130, BB18133, BB23134, BB23135, BB23136, BB31145, BB31146, BB31147, BB31148, BB31149, BB31150, BB36157, BB36158, BB36159, BB36160, BB36161, BB36162, BB43163, BB43164, BB43165, BB43166, BB43167, BB43168, BB47169, BB47170, BB47171, BB47172, BB47173, BB47174, BB47176, BB47177, BC01101, BC01102, BC01103, BC01104, BC01105, BC04106, BC04108, BC04109, BC04110, BC04111, BC04112, BC04113, BC04114, BC04115, BC09117, BC09118, BC09119, BC09120, BC09121, BC09122, BC09123, BC09124, BC09125, BC09126, BC09127, BC09128, BC14131, BC14132, BC14133, BC14134, BC14135, BC14136, BC14137, BC14138, BC14140, BC14141, BC14142, BC14143, BC14144, BC14145, BC19146, BC19147, BC19148, BC19149, BC19150, BC19151, BC19152, BC19153, BC19154, BC19155, BC19156, BC19157, BC21158, BC21159, BC21160, BC21161, BC21162, BC21163, BC21164, BC21166, BC21169, BC21171, BC24172, BC24173, BC24174, BC24175, BC24176, BC24178, BC24180, BC24181, BC30182, BC30183, BC30184, BC30185, BC30186, BC30187, BC30188, BC30189, BC30190, BC30191, BC33192, BC33193, BC33194, BC33195, BC33196, BC33197, BC33198, BC33200, BC33201, BC33202, BC33203, BC33204, BC33206, BC36207, BC36208, BC36209, BC36210, BC36211, BC36212, BC36213, BC36214, BC36215.

Quantity recalled1,056 (418 US, and 638 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0516-2020
FDA event ID: 84186
Recalling firm: Beckman Coulter, Miami, FL
Classification: Class II
Status: Terminated
Recall initiated: 7 Oct 2019
FDA classified: 22 Nov 2019
Reported: 4 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

7 Oct 2019	Recall initiated by company
22 Nov 2019	Classified by FDA	+46 days
4 Dec 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.

Product as listed by the FDA

UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

Where it was distributed

Worldwide distribution - US Nationwide distribution and countries of Australia, Bahrain, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Morocco, Netherlands, New Zealand, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog Number 775222. Serial numbers: AS39017, AS40018, AT35013, AT35014, AT35015, AT35017, AT35018, AT40020, AT40021, AT40022, AT40024, AT40025, AT40027, AT40030, AT45031, AT45032, AT45034, AT45035, AT49037, AT49041, AT49044, AT49045, AT49046, AT49047, AT49048, AT49049, AT49050, AT49051, AT49055, AT49057, AT49058, AT49059, AT49060, AT49061, AT49062, AT49063, AT49064, AT49065, AU01004, AU01005, AU01007, AU01009, AU01010, AU01011, AU01012, AU01014, AU01015, AU01016, AU01017, AU01020, AU01021, AU01022, AU01023, AU01024, AU01025, AU01028, AU01029, AU01030, AU08041, AU08043, AU08044, AU08047, AU08048, AU08049, AU08050, AU11051, AU11053, AU11057, AU11058, AU11059, AU11061, AU11062, AU11063, AU11064, AU11066, AU11068, AU11072, AU13073, AU13075, AU13077, AU13079, AU14083, AU14084, AU14085, AU14086, AU14087, AU14088, AU14090, AU16104, AU16111, AU16112, AU19113, AU19115, AU19118, AU19119, AU19120, AU20123, AU20124, AU20125, AU20128, AU20129, AU20130, AU20131, AU21133, AU21136, AU21137, AU21141, AU23146, AU23147, AU23149, AU23150, AU23151, AU23152, AU28153, AU28154, AU28160, AU28161, AU29163, AU29165, AU29167, AU29168, AU29169, AU29172, AU30173, AU30178, AU30180, AU30181, AU30182, AU35183, AU35185, AU35186, AU35187, AU35188, AU36189, AU36192, AU36193, AU36196, AU36198, AU36200, AU36201, AU36202, AU36203, AU36204, AU40205, AU40207, AU40209, AU40210, AU40211, AU40213, AU40214, AU40215, AU40216, AU40217, AU40218, AU40221, AU43223, AU43225, AU43226, AU43228, AU43229, AU43231, AU43232, AU43233, AU43234, AU43235, AU43237, AU43240, AU49254, AU49256, AU49259, AV01003, AV01004, AV01005, AV01007, AV01009, AV01010, AV01011, AV01012, AV01013, AV01014, AV01016, AV06018, AV06020, AV06023, AV06026, AV06028, AV06030, AV10033, AV10034, AV10035, AV10036, AV10038, AV10039, AV10042, AV10044, AV10045, AV12047, AV12049, AV12054, AV12055, AV12056, AV14057, AV14059, AV14061, AV14062, AV14063, AV16072, AV16073, AV16075, AV16077, AV16078, AV16080, AV16082, AV16083, AV16086, AV16088, AV16089, AV16090, AV16091, AV21092, AV21093, AV21095, AV21096, AV22097, AV22100, AV22102, AV22105, AV22106, AV23107, AV23109, AV23110, AV23111, AV23112, AV23113, AV23116, AV27117, AV27118, AV27120, AV27121, AV36127, AV36128, AV36129, AV36130, AV39131, AV39132, AV39133, AV39134, AV39135, AV40136, AV40137, AV40139, AV40140, AV40143, AV40145, AV42147, AV42149, AV42150, AV42151, AV42152, AV42153, AV42154, AV42155, AV44156, AV44157, AV44158, AV44160, AV44161, AV44162, AV44163, AV44164, AV47167, AV47168, AV47169, AV47170, AV48171, AV48173, AV48174, AV48176, AV48177, AV48178, AV48179, AV49181, AV49183, AV49184, AV49185, AV49187, AV49188, AV49189, AV51191, AV51192, AW01001, AW01002, AW01007, AW01008, AW01010, AW01011, AW01012, AW01013, AW01014, AW01015, AW06016, AW06018, AW06019, AW06020, AW06021, AW06023, AW06024, AW06025, AW06026, AW06027, AW06028, AW06029, AW09031, AW09032, AW09033, AW09034, AW09035, AW10036, AW10037, AW10038, AW10039, AW10040, AW10041, AW10044, AW10045, AW14046, AW14048, AW14049, AW14051, AW16052, AW16053, AW16054, AW16056, AW16057, AW16058, AW16059, AW16060, AW16061, AW20062, AW20063, AW20064, AW20065, AW20066, AW20067, AW20068, AW20069, AW20070, AW20071, AW23072, AW23073, AW23074, AW23075, AW23076, AW23077, AW23078, AW23079, AW28087, AW28088, AW28089, AW28090, AW28091, AW28094, AW28095, AW28096, AW28097, AW28098, AW31099, AW31100, AW31102, AW31103, AW31104, AW31105, AW31106, AW31107, AW31108, AW31109, AW31110, AW35111, AW35112, AW35113, AW35114, AW35115, AW35116, AW35117, AW35120, AW35121, AW35122, AW35123, AW35124, AW35125, AW35126, AW35127, AW35128, AW42129, AW42131, AW42132, AW42133, AW45134, AW45135, AW45136, AW45137, AW45138, AW45139, AW45140, AW45141, AW45143, AW45144, AW45145, AW45146, AW45147, AW47148, AW47149, AW47151, AW47152, AW47153, AW47154, AW47155, AW47156, AW47157, AW49159, AW49160, AW49161, AW49162, AW49163, AW49164, AW49165, AY01001, AY01002, AY01004, AY01005, AY01006, AY01007, AY01008, AY01009, AY01010, AY04011, AY04012, AY04013, AY04015, AY04016, AY04017, AY04018, AY04019, AY04020, AY08021, AY08022, AY08023, AY08024, AY08025, AY08026, AY08027, AY08028, AY08029, AY08032, AY08033, AY08034, AY10036, AY10037, AY10038, AY10039, AY10040, AY10041, AY10042, AY10044, AY10045, AY10046, AY10047, AY10048, AY10049, AY10051, AY10053, AY10054, AY10055, AY17056, AY17057, AY17058, AY17059, AY17060, AY17061, AY17062, AY17063, AY17064, AY17065, AY19066, AY19067, AY19069, AY19070, AY19071, AY19072, AY19073, AY19074, AY19075, AY23076, AY23077, AY23078, AY23079, AY23080, AY23081, AY30085, AY30086, AY30087, AY30088, AY30090, AY32092, AY32093, AY32094, AY32095, AY32096, AY32097, AY32098, AY32099, AY32100, AY32101, AY32102, AY32103, AY32104, AY32105, AY32106, AY35107, AY35108, AY35109, AY35110, AY35111, AY35112, AY35113, AY35114, AY35115, AY35116, AY35117, AY35118, AY35119, AY35120, AY35121, AY40123, AY40124, AY40125, AY40126, AY41127, AY41128, AY41129, AY41130, AY41132, AY41133, AY41134, AY41140, AY41141, AY51142, AY51143, AY51144, AY51145, AY51149, AY52150, AY52151, AY52152, AY52153, AY52154, AY52155, AY52156, AY52157, AY52158, AY52159, AZ02001, AZ02002, AZ02004, AZ02006, AZ02007, AZ02008, AZ02009, AZ02010, AZ06011, AZ06012, AZ06013, AZ06014, AZ06015, AZ06016, AZ06017, AZ06018, AZ06020, AZ06021, AZ06022, AZ08023, AZ08024, AZ08025, AZ08026, AZ08027, AZ08028, AZ08029, AZ08030, AZ08031, AZ12033, AZ12034, AZ12035, AZ12038, AZ12040, AZ12042, AZ12043, AZ12044, AZ17045, AZ17046, AZ17048, AZ17050, AZ17051, AZ17053, AZ18054, AZ18055, AZ18056, AZ18057, AZ19058, AZ19059, AZ19060, AZ19061, AZ20062, AZ20063, AZ20064, AZ20065, AZ20066, AZ20067, AZ20068, AZ20069, AZ20070, AZ22071, AZ22072, AZ22073, AZ22074, AZ22075, AZ23077, AZ23078, AZ23079, AZ23080, AZ24081, AZ24082, AZ24083, AZ24084, AZ24085, AZ25087, AZ25088, AZ25089, AZ25090, AZ28091, AZ28092, AZ28093, AZ28094, AZ28095, AZ28096, AZ28097, AZ28098, AZ28099, AZ28100, AZ34101, AZ34102, AZ34103, AZ34104, AZ34105, AZ34106, AZ34107, AZ34108, AZ34109, AZ34110, AZ34111, AZ34112, AZ34113, AZ34114, AZ34115, AZ39116, AZ39118, AZ39119, AZ39120, AZ39121, AZ39122, AZ39123, AZ39124, AZ39125, AZ41127, AZ41131, AZ41132, AZ41133, AZ41134, AZ41135, AZ43136, AZ43137, AZ43138, AZ43139, AZ43140, AZ43141, AZ43143, AZ46146, AZ46147, AZ46148, AZ46149, AZ46150, AZ46151, AZ46152, AZ46156, AZ46157, AZ46158, AZ46159, AZ48160, AZ48162, AZ48163, AZ48164, AZ48166, AZ48167, AZ49168, AZ49169, AZ49170, AZ49172, AZ49173, AZ49174, AZ49175, AZ49176, BA03001, BA03002, BA03003, BA03004, BA03005, BA03006, BA03007, BA03008, BA03009, BA03010, BA07011, BA07012, BA07013, BA07014, BA07015, BA07016, BA07017, BA07018, BA07019, BA07020, BA08021, BA08022, BA08023, BA08024, BA08025, BA10026, BA10027, BA10028, BA10029, BA10030, BA10031, BA13032, BA13034, BA13035, BA13036, BA13037, BA13038, BA13039, BA13040, BA13041, BA15042, BA15045, BA16047, BA16048, BA16049, BA16050, BA17052, BA17053, BA17054, BA18055, BA18056, BA18057, BA19060, BA19061, BA19062, BA21064, BA22067, BA22068, BA22069, BA22070, BA23071, BA23072, BA23073, BA24075, BA24076, BA24077, BA24078, BA25080, BA25081, BA25082, BA25083, BA25084, BA25085, BA27086, BA27087, BA27088, BA27089, BA27090, BA29091, BA29092, BA29093, BA29094, BA29095, BA31096, BA31097, BA31098, BA31099, BA31100, BA35101, BA35103, BA35104, BA35105, BA36106, BA36107, BA37109, BA37110, BA37111, BA37112, BA38113, BA38114, BA38115, BA40116, BA40117, BA40118, BA41119, BA41120, BA41121, BA41122, BA43124, BA43126, BA46127, BA46128, BA46129, BA46130, BA48131, BA48132, BA48133, BA49134, BA49135, BA49136, BA49137, BA50138, BA50139, BA50140, BA50141, BA50142, BB03001, BB03002, BB03003, BB03004, BB04005, BB04006, BB05007, BB05008, BB05009, BB06010, BB09011, BB09012, BB09013, BB09014, BB09015, BB16016, BB16017, BB16018, BB16019, BB16021, BB16022, BB16023, BB23024, BB23025, BB23026, BB23027, BB23028, BB27029, BB27030, BB27031, BB27032, BB27033, BB27034, BB47045, BB47046, BB47047, BB47048, BB47049, BB47050, BB47051, BB47052, BB47053, BB47054, BC01001, BC01002, BC01003, BC01004, BC04006, BC04007, BC04008, BC10016, BC10017, BC10018, BC10019, BC14021, BC14022, BC14023, BC14024, BC21026, BC21027, BC29030, BC29031, BC29032, BC29035, BC30036, BC30039. Catalog Number B66705. Serial Numbers: AZ30002, AZ30003, AZ30004, AZ39005, BA14002. Catalog Number C11477. Serial Numbers: BB11109, BB11110, BB12111, BB12117, BB12118, BB12119, BB12120, BB12121, BB12122, BB12123, BB18124, BB18125, BB18126, BB18127, BB18128, BB18129, BB18130, BB18133, BB23134, BB23135, BB23136, BB31145, BB31146, BB31147, BB31148, BB31149, BB31150, BB36157, BB36158, BB36159, BB36160, BB36161, BB36162, BB43163, BB43164, BB43165, BB43166, BB43167, BB43168, BB47169, BB47170, BB47171, BB47172, BB47173, BB47174, BB47176, BB47177, BC01101, BC01102, BC01103, BC01104, BC01105, BC04106, BC04108, BC04109, BC04110, BC04111, BC04112, BC04113, BC04114, BC04115, BC09117, BC09118, BC09119, BC09120, BC09121, BC09122, BC09123, BC09124, BC09125, BC09126, BC09127, BC09128, BC14131, BC14132, BC14133, BC14134, BC14135, BC14136, BC14137, BC14138, BC14140, BC14141, BC14142, BC14143, BC14144, BC14145, BC19146, BC19147, BC19148, BC19149, BC19150, BC19151, BC19152, BC19153, BC19154, BC19155, BC19156, BC19157, BC21158, BC21159, BC21160, BC21161, BC21162, BC21163, BC21164, BC21166, BC21169, BC21171, BC24172, BC24173, BC24174, BC24175, BC24176, BC24178, BC24180, BC24181, BC30182, BC30183, BC30184, BC30185, BC30186, BC30187, BC30188, BC30189, BC30190, BC30191, BC33192, BC33193, BC33194, BC33195, BC33196, BC33197, BC33198, BC33200, BC33201, BC33202, BC33203, BC33204, BC33206, BC36207, BC36208, BC36209, BC36210, BC36211, BC36212, BC36213, BC36214, BC36215.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Beckman Coulter

All 334

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
12 Aug 2026Device	CLASS II	REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US) recalled	Beckman Coulter	Other	Nationwide
12 Aug 2026Device	CLASS II	REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled	Beckman Coulter	Other	Nationwide
29 Apr 2026Device	CLASS II	Access Total T4 Calibrator recalled by Beckman Coulter	Beckman Coulter	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide