CD11b APC: ASR — Class II medical device recall Z-0641-2024
Ongoing recall by Becton, Dickinson and Company, BD Biosciences, reported 2024-01-17, distributed nationwide. In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signa
| Recall number | Z-0641-2024 |
|---|---|
| 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 | 2023-10-25 |
| Classified | 2024-01-05 |
| Reported by FDA | 2024-01-17 |
| Distributed | Nationwide (US) |
| Quantity | 464 vials |
| UPC / GTIN / UDI-DI | 00382903331437, 00382903409365 |
| Model numbers | 333143, 340936 |
Product
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Reason for recall
In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.
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-0641-2024. 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.