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 fl…

Recall date

January 29, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1125-2021

FDA classification

Class II

Brand / firm

Confirm Biosciences Inc

Sold / distributed

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countr…

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.