Confirm Biosciences Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral floClass IIJan 29, 2021Due to two (2) issues: 1) The firm distributed COVID-19 Rap	Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Aut	Class IIDevices	Jan 29, 2021
Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateClass IIJan 29, 2021Due to two (2) issues: 1) The firm distributed COVID-19 Rap	Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Aut	Class IIDevices	Jan 29, 2021