Device product
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
Z-0678-2022
Product summary
- Event
- Event 89493
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 kits
- Official record key
device-enforcement:Z-0678-2022
Official wording
Reason: The product was incorrectly shipped at room temperature rather than refrigerated.
Code information: Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023.
Distribution pattern: US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.
Derived failure modes
-
Unknown
The product was incorrectly shipped at room temperature rather than refrigerated.