Reported Sep 8, 2021 · Terminated
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Thera Test Laboratories, Inc.
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: Thera Test Laboratories, Inc. · 1120 N Du Page Ave · Lombard, IL · 60148-1247
Is this the product you have?
EL-Anti-SARS-CoV-2 IgM KitCatalog #104-129IVD. Submitted as EUA202129
- Lot codes and dates
Kit lot numbers 05204350exp. 05/01/202105204367exp. 05/19/2021and 06204432exp. 05/19/2021
- Amount recalled
- 11 kits
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
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
This product could cause temporary or reversible health problems — stop using it.
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