Reported Aug 26, 2020 · Terminated
Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the…
Chembio Diagnostics, 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: Chembio Diagnostics, Inc · 3661 Horseblock Rd · Medford, NY · 11763-2215
Is this the product you have?
- Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA
- Model Number70-1069-0
- Lot codes and dates
- Lot Numbers83716171 83720151 83720153
- Amount recalled
- 126 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
- Nationwide
Why it was recalled
FDA revocation of the Emergency Use Authorization due to performance issues
This product could cause temporary or reversible health problems — stop using it.
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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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