meridian bioscience immunocard STAT! Rotavirus test — Class II medical device recall Z-0678-2022
Terminated recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2022-03-02, distributed in FL, IL, LA, MS, NC, OH, TX. The product was incorrectly shipped at room temperature rather than refrigerated.
| Recall number | Z-0678-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2022-01-25 |
| Classified | 2022-02-24 |
| Reported by FDA | 2022-03-02 |
| Terminated | 2023-01-09 |
| Distributed | FL, IL, LA, MS, NC, OH, TX |
| Quantity | 19 kits |
| Lot numbers | 750030M481, 750030N482, 750030N483 |
| Model numbers | 750030 |
| Expiration dates | 2022-04-29, 2022-12-02, 2023-05-17 |
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 for recall
The product was incorrectly shipped at room temperature rather than refrigerated.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0678-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.