BD FACS 7-color Setup beads BD Biosciences — Class II medical device recall Z-2397-2012
Terminated recall by BD Biosciences, Systems & Reagents, reported 2012-09-26, distributed nationwide. Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
| Recall number | Z-2397-2012 |
|---|---|
| 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 | 2012-06-29 |
| Classified | 2012-09-17 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-03-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CL, KR, MX, SG, TW |
| Quantity | 96 kits |
| Lot numbers | 33412 |
| Model numbers | 335775 |
Product
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
Reason for recall
Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
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-2397-2012. 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.