Z-1977-2014Class II

BD FACS Canto and associated Fluidics Cart

Name: Z-1977-2014 BD FACS Canto and associated Fluidics Cart
Creator: BD Biosciences, Systems & Reagents
Published: 2014-06-06
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2014-06-06 / Terminated / root cause: manufacturing process

FDA source

BD Biosciences, Systems & Reagents began a recall of BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics on 2014-06-06. FDA classified it as Class II and gives the reason as "Laser cooling fans and internal fan of the associated fluidics cart are not operational". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1977-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-06
Posted: 2014-07-02
Terminated: 2015-01-27
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
Product code: OYE Flow Cytometric Reagents And Accessories.
Reason for recall: Laser cooling fans and internal fan of the associated fluidics cart are not operational.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BD sent an Important Product Recall notification letters dated June 2014 to affected US customers by trackable mail. International affiliates were notified on June 6, 2014. The letter identified the affected product, problem and the actions to be taken. A Field Change notification has been established and a BD field Service Engineer will coordinate with each account to perform the necessary corrections. Questions or concerns may be directed to BD Customer Support at BD Biosciences, prompt 2. Out of US customers are to contact local BD rep with questions.
Quantity in commerce: 35 installed devices
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1977-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1977-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01

Product code OYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)