FDA-Device2017-06-07Class II
Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Cell Marque Corporation
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.
Sold states
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
Affected count
8
Manufactured in
6600 Sierra College Blvd, Rocklin, CA, United States
Products
Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2201-2017Don't want to check this manually?
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