ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | April 01, 2026 |
| Reported | May 20, 2026 |
| Recalling firm | Aniara Diagnostica LLC |
| Country / region | United States OH |
Hazard
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Affected products
- ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
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