FDA Enforcement
Class II
Ongoing
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Recall: Z-2171-2026
·
Reported May 20, 2026
Enforcement
- Recall Number
- Z-2171-2026
- Event ID
- 98754
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Aniara Diagnostica LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 20, 2026
- Initiation Date
- April 1, 2026
- Classification Date
- May 12, 2026
- Address
- 7768 Service Center Dr, West Chester, OH, 45069-2442, United States
Description
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Reason
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Code Info
UDI-DI: 03663537018763; Lot Number: FD1265
Distribution
US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Quantity
359 units