Recall Z-1126-2021— Confirm Biosciences Inc
Class II · Terminated
Class II FDA medical device recall by Confirm Biosciences Inc, initiated 2021-01-29, terminated 2022-12-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum.. Reason: Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing)..
- Recalling firm
- Confirm Biosciences Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-29
- Terminated
- 2022-12-13
- Firm location
- San Diego, CA, United States
Product description
Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum.
Reason for recall
Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).
Data sourced from openFDA. This site is unofficial and independent of the FDA.