FDAMay 10, 2016device

SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods.

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

The hazard

Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.

What to do

FDA enforcement status: Terminated

Brands named

cell marquecell

Recall history

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

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