FDAOctober 25, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

becton dickinson and company bd biosciencesbectonbecton dickinson

UPCs

0038290340936500382903331437

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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