Reported Aug 28, 2019 · Terminated
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
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 MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
- Lot codes and dates
F1701084F1900611
- Amount recalled
- 51
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Residual crystallization of the microplate and recurrent negative controls out of range.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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