BD Anti-Kappa PE — Class II medical device recall Z-1215-2022
Ongoing recall by Becton, Dickinson and Company, BD Biosciences, reported 2022-06-08, distributed nationwide. Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
| Recall number | Z-1215-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2022-03-25 |
| Classified | 2022-06-01 |
| Reported by FDA | 2022-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | TW |
| Quantity | 199 units |
| UPC / GTIN / UDI-DI | 00382903465873 |
| Lot numbers | 1228977 |
| Model numbers | 346587 |
Product
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
Reason for recall
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
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-1215-2022. 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.