Medical Device Recall: CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Becton, Dickinson and Company, BD Biosciences · October 25, 2023
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.
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.
States Affected
NATIONWIDE
Quantity Affected
464 Vials
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0641-2024
Status: ongoing
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