Reported Sep 8, 2021 · Terminated
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
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 IgG KitCatalog #104-130. Submitted as EUA202128
- Lot codes and dates
Lot numbers 05204351exp. 5/1/2021and 05204368exp. 05/19/2021
- Amount recalled
- 19 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
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
This product could cause temporary or reversible health problems — stop using it.
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