BD FACS Canto Flow Cytometer Recalled for Non-Operational Cooling Fans
BD Biosciences is recalling 35 BD FACS Canto flow cytometers and associated fluidics carts because the laser cooling fans and internal fans are not operational.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall involving a functional defect without immediate reported harm.
Plain-English summary
BD Biosciences, Systems & Reagents is recalling 35 installed units of the BD FACS Canto flow cytometer and associated Fluidics Cart. These devices are used for in vitro diagnostics. The recall is due to a defect where the laser cooling fans and the internal fan of the associated fluidics cart are not operational.
The affected devices were distributed worldwide, including nationwide in the United States across the states of California, Ohio, Rhode Island, Georgia, Florida, Maryland, New York, West Virginia, New Jersey, Massachusetts, Connecticut, Iowa, New Mexico, and Minnesota, as well as in China and Belgium. Specific serial numbers for the affected units are listed in the official recall documentation.
No injuries or illnesses have been reported in connection with this recall. Users of these devices should contact BD Biosciences for instructions on how to address the non-operational fans.
The recalled product
- Product
- BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
- Manufacturer
- BD Biosciences, Systems & Reagents
- Category
- Medical Device — Flow Cytometer
- Hazard
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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