FDASeptember 30, 2015device

BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.

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

The hazard

Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.

What to do

FDA enforcement status: Terminated

Brands named

becton dickinson and company bd biosciencesbectonbecton dickinson

Recall history

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

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