CLASS II ONGOING Device recall · Reported 9 Oct 2024 · FDA Enforcement Report

BD FACSDuet Premium Sample Preparation System recalled

Becton, Dickinson and Company, BD Bio Sciences is recalling BD FACSDuet Premium Sample Preparation System, distributed in 13 states. The recall was initiated on 12 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF/UDI-DI/Serial Numbers: 666340/382906663405/9230010101, 9230010102, 9230010103, 9230010104, 9230010105, 9230010107, 9230010108, 9230010109, 9230010112, 9230010113, 9230010114, 9230010115, 9230010116, 9230010118, 9230010119, 9230010120. 666339/9230000102, 9230000103, 9230000104, 9230000105, 9230000106, 9230000112, 9230000113, 9230000114, 9230000118, 9230000120, 9230000121, 9230000123, 9230000124, 9230000126, 9230000128, 9230000130, 9230000132, 9230000134, 9230000135, 9230000138, 9230000144, 9230000145, 9230000131, 9230000152, 9230000149, 9230000030, 9230000101, 9230000108, 9230000109, 9230000110, 9230000111, 9230000115, 9230000116, 9230000117, 9230000119, 9230000122, 9230000125, 9230000127, 9230000129, 9230000136, 9230000139, 9230000141, 9230000142, 9230000143. 663128/382906631282/9220030004, 9220030005, 9220030008, 9220030016, 9220030017, 9220030027, 9220030029, 9220030031, 9220030043, 9220030053, 9220030057. 662588/9220010119, 9220010179, 9220010182, 9220010232, 9220010236, 9220010250, 9220010265, 9220010275, 9220010293, 9220010311, 9220010313, 9220010316, 9220010324, 9220010327, 9220010335, 9220010338, 9220010341, 9220010344, 9220010348, 9220010349, 9220010292, 9220010112, 9220010120, 9220010125, 9220010127, 9220010128, 9220010130, 9220010133, 9220010138, 9220010154, 9220010161, 9220010183, 9220010188, 9220010197, 9220010215, 9220010225, 9220010231, 9220010238, 9220010240, 9220010242, 9220010244, 9220010256, 9220010257, 9220010260, 9220010263, 9220010268, 9220010269, 9220010279, 9220010280, 9220010289, 9220010290, 9220010294, 9220010296, 9220010329, 9220010332, 9220010345, 9220010354, 9230000031, 99220010292.

Quantity recalled130

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-0009-2025
FDA event ID: 95215
Recalling firm: Becton, Dickinson and Company, BD Bio Sciences, Milpitas, CA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Aug 2024
FDA classified: 3 Oct 2024
Reported: 9 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Medical Software

Timeline

12 Aug 2024	Recall initiated by company
3 Oct 2024	Classified by FDA	+52 days
9 Oct 2024	Published in enforcement report	+6 days

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

Reason for recall

Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.

Where it was distributed

US: NJ, UT, WI, TX, ID, AK, MN, MA, MD, TN, MI, CA, VA OUS: Ireland, Austria, Italy, Germany, Belgium, Finland, Canada, France, Spain, New Zealand, United Kingdom, Japan, Australia, Norway, Singapore, Sweden, Turkey, Brazil, Colombia, Netherlands, United Arab Emirates, Saudi Arabia, Mexico, Switzerland, Costa Rica, China, Azerbaijan, Algeria, Jordan, India

Alaska California Idaho Massachusetts Maryland Michigan Minnesota New Jersey Tennessee Texas Utah Virginia Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

REF/UDI-DI/Serial Numbers: 666340/382906663405/9230010101, 9230010102, 9230010103, 9230010104, 9230010105, 9230010107, 9230010108, 9230010109, 9230010112, 9230010113, 9230010114, 9230010115, 9230010116, 9230010118, 9230010119, 9230010120. 666339/9230000102, 9230000103, 9230000104, 9230000105, 9230000106, 9230000112, 9230000113, 9230000114, 9230000118, 9230000120, 9230000121, 9230000123, 9230000124, 9230000126, 9230000128, 9230000130, 9230000132, 9230000134, 9230000135, 9230000138, 9230000144, 9230000145, 9230000131, 9230000152, 9230000149, 9230000030, 9230000101, 9230000108, 9230000109, 9230000110, 9230000111, 9230000115, 9230000116, 9230000117, 9230000119, 9230000122, 9230000125, 9230000127, 9230000129, 9230000136, 9230000139, 9230000141, 9230000142, 9230000143. 663128/382906631282/9220030004, 9220030005, 9220030008, 9220030016, 9220030017, 9220030027, 9220030029, 9220030031, 9220030043, 9220030053, 9220030057. 662588/9220010119, 9220010179, 9220010182, 9220010232, 9220010236, 9220010250, 9220010265, 9220010275, 9220010293, 9220010311, 9220010313, 9220010316, 9220010324, 9220010327, 9220010335, 9220010338, 9220010341, 9220010344, 9220010348, 9220010349, 9220010292, 9220010112, 9220010120, 9220010125, 9220010127, 9220010128, 9220010130, 9220010133, 9220010138, 9220010154, 9220010161, 9220010183, 9220010188, 9220010197, 9220010215, 9220010225, 9220010231, 9220010238, 9220010240, 9220010242, 9220010244, 9220010256, 9220010257, 9220010260, 9220010263, 9220010268, 9220010269, 9220010279, 9220010280, 9220010289, 9220010290, 9220010294, 9220010296, 9220010329, 9220010332, 9220010345, 9220010354, 9230000031, 99220010292.

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 Becton, Dickinson and Company, BD Bio Sciences

All 10

Reported	Class	Recall	Company	Reason	Where
13 Aug 2025Device	CLASS II	BD Trucount Controls, 30 Test recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Bio Sciences	Processing Deviation	Nationwide
13 Aug 2025Device	CLASS II	BD Trucount Controls, 30 Test recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Bio Sciences	Processing Deviation	Nationwide
9 Jul 2025Device	CLASS II	REF: 335775 , BD Facs, 7-Color Setup Beads, 25 setups per kit, Rx recalled	Becton, Dickinson and Company, BD Bio Sciences	Other	37 states
9 Jul 2025Device	CLASS II	REF: 666289 , BD Facs, 7-Color Setup Beads, 25 Runs, CE recalled	Becton, Dickinson and Company, BD Bio Sciences	Other	37 states
1 Jan 2025Device	CLASS II	Device Description: FACSLyric 2L6C Instrument US recalled	Becton, Dickinson and Company, BD Bio Sciences	Device Malfunction	Nationwide

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