Reported May 20, 2026 · Ongoing
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Aniara Diagnostica LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aniara Diagnostica LLC · 7768 Service Center Dr · West Chester, OH · 45069-2442
Is this the product you have?
- ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
- Lot codes and dates
- UDI-DI03663537018763
- Lot NumberFD1265
- Amount recalled
- 359 units
Where it was sold
Why it was recalled
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
This product could cause temporary or reversible health problems — stop using it.
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