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Cell Marque Corporation recalls Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Spec
Recalled June 7, 2017 · FDA recall Z-2199-2017 · Cell Marque
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. · FDA Class II
Units
12
Sold at
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
Description
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.
Product
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
Manufacturer(s)
Cell Marque Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →