Recall Z-2204-2017— Cell Marque Corporation
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: Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - 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
Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - 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.