Z-0678-2022 Class II Terminated
FDA device recall Z-0678-2022 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Jan 25, 2022 and is designated Class II. Reason for recall: The product was incorrectly shipped at room temperature rather than refrigerated. The recall status is terminated (terminated Jan 9, 2023). Affected quantity: 19 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 2, 2022
- Initiation Date
- Jan 25, 2022
- Termination Date
- Jan 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0678-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026