Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-0641-2024

Z-0641-2024 Class II Ongoing

Recalled by Becton, Dickinson and Company, BD Biosciences — San Jose, CA

Recall Details

Product Type
Devices
Report Date
January 17, 2024
Initiation Date
October 25, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
464 Vials

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.

Distribution Pattern

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.

Code Information

REF/UDI-DI/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228

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