Recall Z-2201-2017— Cell Marque Corporation

Name: FDA recall Z-2201-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-05

Class II · Terminated

Class II FDA medical device recall by Cell Marque Corporation, initiated 2017-05-05, terminated 2017-09-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent. Reason: 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..

Recalling firm: Cell Marque Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-05-05
Terminated: 2017-09-07
Firm location: Rocklin, CA, United States

Product description

Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.