Confirm Biosciences Inc: Medical Device Recalls in 2021

Updated on March 25, 2026.

According to to data from the FDA, there were 2 medical device recalls made by Confirm Biosciences Inc in 2021. See the details of the recalls below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

2021

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.
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-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.