Z-2203-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- May 5, 2017
- Termination Date
- September 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - 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.
Distribution Pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
Code Information
7.0 ml lot 11515602A, expiry 2018-05.