Reported Jun 9, 2021 · Completed
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the 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, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
- 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
Antigen Rapid Test Kit 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.
Want the full recall guide?
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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