FDA Enforcement
Class II
Terminated
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.
Recall: Z-0678-2022
·
Reported March 2, 2022
Enforcement
- Recall Number
- Z-0678-2022
- Event ID
- 89493
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 2, 2022
- Initiation Date
- January 25, 2022
- Classification Date
- February 24, 2022
- Termination Date
- January 9, 2023
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
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
The product was incorrectly shipped at room temperature rather than refrigerated.
Code Info
Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023.
Distribution
US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.
Quantity
19 kits