Z-2210-2017 Class II Terminated
FDA device recall Z-2210-2017 was initiated by Cell Marque Corporation on May 5, 2017 and is designated Class II. 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… The recall status is terminated (terminated September 7, 2017). Affected quantity: 11.
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
- 11
Product Description
HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-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
1.0 ml lot 1626403D, expiry 2019-08; 7.0 mL lot. 1625207H, expiry 2019-08;