Z-2205-2017 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
- 3
Product Description
Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - 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.
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 1432301A, expiry 2017-10; lot 1525206A , expiry 201 8-08.