Device product
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Z-0641-2024
Product summary
- 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
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.