CLASS II Device recall · Reported 9 Jul 2014 · FDA Enforcement Report

BD FACS Canto and associated Fluidics Cart recalled

BD Biosciences, Systems & Reagents is recalling BD FACS Canto and associated Fluidics Cart, distributed nationwide in the US. The recall was initiated on 6 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFACS Canto: model number 657338; Associates Fluidic Cart (catalog number 6657660)- IVD; Serial numbers: V65733800001, V65733800002, V65733800003, V65733800004 V65733800005, V65733800006, V65733800007, V65733800008, V65733800009, V657338000010, V657338000011, V657338000012, V657338000013, V657338000014, V657338000017, V657338000018, V657338000019, V657338000020, V657338000021, V657338000022, V657338000023, V657338000024, V657338000025, V657338000026, V657338000028, V657338000029, V657338000031, V657338000032, V657338000033, V657338000034, V65733800035, V65733800036, V65733800037, V65733800038, V65733800039, V657338000040 V657338000043, V657338000044, V657338000045, V657338000046, V657338000047, V657338000048, V657338000049, V657338000050, V657338000051, V657338000052, V657338000053, V657338000054, V657338000055, V657338000056, V657338000057, V657338000058, V657338000060.

Quantity recalled35 installed devices

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-1977-2014
FDA event ID: 68490
Recalling firm: BD Biosciences, Systems & Reagents, San Jose, CA
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2014
FDA classified: 1 Jul 2014
Reported: 9 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

6 Jun 2014	Recall initiated by company
1 Jul 2014	Classified by FDA	+25 days
9 Jul 2014	Published in enforcement report	+8 days

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

Reason for recall

Laser cooling fans and internal fan of the associated fluidics cart are not operational.

Product as listed by the FDA

BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium.

Nationwide California Connecticut Florida Georgia Iowa Maryland Minnesota New Jersey New Mexico New York Ohio Rhode Island West Virginia

Questions about this recall

Is BD FACS Canto and associated Fluidics Cart recalled?

Yes. BD Biosciences, Systems & Reagents recalled BD FACS Canto and associated Fluidics Cart on 6 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-1977-2014.

Why was it recalled?

Laser cooling fans and internal fan of the associated fluidics cart are not operational.

Which lots are affected?

FACS Canto: model number 657338; Associates Fluidic Cart (catalog number 6657660)- IVD; Serial numbers: V65733800001, V65733800002, V65733800003, V65733800004 V65733800005, V65733800006, V65733800007, V65733800008, V65733800009, V657338000010, V657338000011, V657338000012, V657338000013, V657338000014, V657338000017, V657338000018, V657338000019, V657338000020, V657338000021, V657338000022, V657338000023, V657338000024, V657338000025, V657338000026, V657338000028, V657338000029, V657338000031, V657338000032, V657338000033, V657338000034, V65733800035, V65733800036, V65733800037, V65733800038, V65733800039, V657338000040 V657338000043, V657338000044, V657338000045, V657338000046, V657338000047, V657338000048, V657338000049, V657338000050, V657338000051, V657338000052, V657338000053, V657338000054, V657338000055, V657338000056, V657338000057, V657338000058, V657338000060.

Where was it sold?

Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium.

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

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