Reported Jun 9, 2021 · Completed
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative…
Lepu Medical Technology (beijing) Co., Ltd.
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: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD · Building 7-1 · Beijing · N/A
Is this the product you have?
- Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
- Lot codes and dates
- All Lots distributed within the U.S.
- Amount recalled
- 8, 419, 545 units in total
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
Stop using this product now
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is 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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