Z-0641-2024 Class II Ongoing
FDA device recall Z-0641-2024 was initiated by Becton, Dickinson and Company, BD Biosciences on October 25, 2023 and is designated Class II. 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 ma… The recall status is ongoing. Affected quantity: 464 Vials.
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