CLASS II Device recall · Reported 26 Aug 2020 · FDA Enforcement Report
Chembio DPP Covid-19 IgM/IgG System- Rrapid recalled
Chembio Diagnostics is recalling Chembio DPP Covid-19 IgM/IgG System- Rrapid immunochromatographic test for the, distributed nationwide in the US. The recall was initiated on 18 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2807-2020
- FDA event ID
- 86098
- Recalling firm
- Chembio Diagnostics, Medford, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jun 2020
- FDA classified
- 14 Aug 2020
- Reported
- 26 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Jun 2020 | Recall initiated by company | |
| 14 Aug 2020 | Classified by FDA | +57 days |
| 26 Aug 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
FDA revocation of the Emergency Use Authorization due to performance issues
Product as listed by the FDA
Chembio DPP COVID-19 IgM/IgG System- Rrapid 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 Number: 65-9569-0
Where it was distributed
Nationwide
Questions about this recall
Is Chembio DPP Covid-19 IgM/IgG System- Rrapid immunochromatographic test for the recalled?
Yes. Chembio Diagnostics recalled Chembio DPP Covid-19 IgM/IgG System- Rrapid immunochromatographic test for the on 18 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2807-2020.
Why was it recalled?
FDA revocation of the Emergency Use Authorization due to performance issues
Which lots are affected?
Lot Numbers: CV041020/A CV041520 CV040220/A1 CV042420 CV042920 CV040320/A2 CV050120
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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