Z-0678-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 2, 2022
- Initiation Date
- January 25, 2022
- Termination Date
- January 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 kits
Product Description
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.
Reason for Recall
The product was incorrectly shipped at room temperature rather than refrigerated.
Distribution Pattern
US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.
Code Information
Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023.