CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Reported: January 17, 2024 Initiated: October 25, 2023 #Z-0641-2024
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.
Details
- Recalling Firm
- Becton, Dickinson and Company, BD Biosciences
- Units Affected
- 464 Vials
- Distribution
- Worldwide - US Nationwide distribution including in the states of IL, MN, FL, MI, MD, NC, NY, CA, GA, AR, KS, PA, NH, TX, OK, MA, MO, DC, AZ, IN, NJ, TN, WA, VA, CT and the countries of CA, BE, SG, HK, TW, BR, MY, IN, BO, PE, JP, MX, CL, KR, UY, AU.
- Location
- San Jose, CA
Frequently Asked Questions
What product was recalled? ▼
CD11b APC: ASR, REF: 340936, and CE, REF: 333143. Recalled by Becton, Dickinson and Company, BD Biosciences. Units affected: 464 Vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0641-2024.
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