BD FACS Canto and associated Fluidics Cart Product Usage: Flow… — Class II medical device recall Z-1977-2014
Terminated recall by BD Biosciences, Systems & Reagents, reported 2014-07-09, distributed nationwide. Laser cooling fans and internal fan of the associated fluidics cart are not operational.
| Recall number | Z-1977-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD Biosciences, Systems & Reagents, San Jose, CA, United States |
| Recall initiated | 2014-06-06 |
| Classified | 2014-07-01 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2015-01-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CN |
| Quantity | 35 installed |
| UPC / GTIN / UDI-DI | 00657338000013, 00657338000020, 00657338000044, 00657338000051 |
| Serial numbers | V65733800001, V657338000010, V657338000011, V657338000012, V657338000013, V657338000014, V657338000017, V657338000018, V657338000019, V65733800002, V657338000020, V657338000021, V657338000022, V657338000023, V657338000024, V657338000025, V657338000026, V657338000028, V657338000029, V65733800003, V657338000031, V657338000032, V657338000033, V657338000034, V65733800004 and 28 more |
| Model numbers | 657338, 6657660 |
Product
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
Reason for recall
Laser cooling fans and internal fan of the associated fluidics cart are not operational.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1977-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.