FDA DevicesClass II
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Published: May 20, 2026Recall ID: Z-2171-2026Category: devicesCountry: US
Reason for Recall / 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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Product Description & Identification
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Additional Source Details
| Field | Value |
|---|---|
| City | West Chester |
| State | OH |
| Event id | 98754 |
| Address 1 | 7768 Service Center Dr |
| Code info | UDI-DI: 03663537018763; Lot Number: FD1265 |
| Postal code | 45069-2442 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 359 units |
| Reason for recall | Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260401 |
| Initial firm notification | Letter |
| Center classification date | 20260512 |
Overview
- Recalling FirmAniara Diagnostica LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI