Recall Z-0641-2024— Becton, Dickinson and Company, BD Biosciences
Class II · Ongoing
Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2023-10-25. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-25
- Firm location
- San Jose, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.