medical Class II Updated 2024-01-17

Becton, Dickinson and Company, BD Biosciences recalls CD11b APC: ASR, REF: 340936, and CE, REF: 333143

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF/UDI-DI/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228
View official government recall

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