FDAMay 5, 2017device

Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

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

The hazard

Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.

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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