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Confirm Biosciences Recalls
2 recalls on record · February 24, 2021 to February 24, 2021 · Medical Devices
February 24, 2021Medical DevicesFDA
Confirm Biosciences Inc recalls Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a late
Hazard: 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).
February 24, 2021Medical DevicesFDA
Confirm Biosciences Inc recalls Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flo
Hazard: 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).