FDA Device recall Z-0641-2024
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of CD11b APC: ASR, REF: 340936, and CE, REF: 333143 by Becton Dickinson And Bd Biosciences, citing 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 misdiagnosi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0641-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-25 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | US |
Product
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Reason
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.
Identifiers
| code_info | REF/UDI-DI/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0641-2024%22
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