Reported Mar 16, 2022 · Ongoing
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
Lusys Laboratories, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Lusys Laboratories, Inc. · 7220 Trade St Ste 338 · San Diego, CA · 92121-2324
Is this the product you have?
- COVID-19 IgG/IGM Antibody Test For Detection of COVID-19
- IgG and IgM antibodies Catalog NoI-111
- Lot codes and dates
- Part NumberI-111
- Lot NumbersAll Lots due to not having an authorized Emergency Use Authorization (EUA)
- Amount recalled
- 33,955 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Using this product could cause serious injury, illness or death — stop using it now.
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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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