FDAJune 18, 2020device
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 N...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
FDA revocation of the Emergency Use Authorization due to performance issues
What to do
FDA enforcement status: Terminated
Brands named
chembio diagnosticschembio
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDADimension Creatinine Flex reagent cartridge. Material Number: 10872079.2026-03-18
- FDALeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) ...2026-03-13
- FDA(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the fo...2026-03-13
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