FDA Device recall Z-0678-2022
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box
- FDA Device
- Class II
- terminated
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class II recall of meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box by Medline Industries Northfield, citing the product was incorrectly shipped at room temperature rather than refrigerated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0678-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-25 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | FL, IL, LA, MS, NC, OH, TX |
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.
Reason
The product was incorrectly shipped at room temperature rather than refrigerated.
Identifiers
| code_info | Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0678-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.