Device product
Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
Z-2573-2018
Product summary
- Event
- Event 80441
- Status
- Terminated
- Classification
- Class III
- Quantity
- 505
- Official record key
device-enforcement:Z-2573-2018
Official wording
Reason: Contains a gel-like contaminant that may affect product performance.
Code information: Lot S0406 Exp. 05/31/2018
Distribution pattern: AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI
Derived failure modes
-
Unknown
Contains a gel-like contaminant that may affect product performance.