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Recall Observatory FDA recall evidence

Device product

CD11b APC: ASR, REF: 340936, and CE, REF: 333143

Z-0641-2024

October 25, 2023

Class II

Product summary

Firm
Becton, Dickinson and Company, BD Biosciences
Event
Event 93569
Status
Ongoing
Classification
Class II
Quantity
464 Vials
Official record key
device-enforcement:Z-0641-2024

Official wording

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.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.