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
Reported: August 26, 2020 Initiated: June 18, 2020 #Z-2807-2020
Product Description
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
Reason for Recall
FDA revocation of the Emergency Use Authorization due to performance issues
Details
- Recalling Firm
- Chembio Diagnostics, Inc
- Units Affected
- 7,674 kits (153,480 devices)
- Distribution
- Nationwide
- Location
- Medford, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Chembio Diagnostics, Inc. Units affected: 7,674 kits (153,480 devices).
Why was this product recalled? ▼
FDA revocation of the Emergency Use Authorization due to performance issues
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2020. Severity: Moderate. Recall number: Z-2807-2020.
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