Confirm Biosciences Inc: 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.

Recall number

Z-1126-2021

Recalling firm

Confirm Biosciences Inc

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.

Status

Terminated

Initiated

2021-01-29

Posted

not on file

Terminated

2022-12-13

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).

Root cause

Other

Action

On 01/29/2021, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Notification its customers and distributors informing them that Recalling Firm may have distributed products to facilities that do not meeting the conditions outline in the Emergency Use Authorization (EUA) which stipulates that only laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity tests are authorized to receive and utilize the products. Use of these tests by non-certified laboratory facilities may result in false-positive test results and may lead to an incorrect assessment, such as mistaken immune response to the COVID-19 virus and may delay treatment and risk the further spread of infection to others. The Recalling Firm is planning on sending a follow-up Customer Notification Letter via UPS on or about 02/12/2021. The "URGENT: MEDICAL DEVICE RECALL" Notification instructs customers: 1) To minimize unauthorized use of these products, discontinue the use these products outside of a CLIA accredited or compliant Moderate or High Complexity laboratory setting. 2) Acknowledge the receipt of this notice by completing the attached Response Form, scanning and emailing the completed form to: Regulatory@confirmbiosciences.com Customer are asked to complete the response form and return immediately, no later than March 31, 2021. To correct this issue, the Recalling Firm will work with its customers to either: -Affirm the Customers authorization to use these products through their CLIA Number and Status -Coordinate the return of unused, unopened products to the Recalling Firm. For any questions regarding this recall, call 800-908-5602 or email Regulatory@confirmbiosciences.com (Monday thru Friday 8:00 a.m. to 4:00 p.m. Pacific Time)

Quantity

2,003,053 cassettes

Distribution

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 countries of Australia, Mexico, Honduras, Spain, Sierra Leone, Bahamas, Ecuador, Turkey, Romania, Kuwait, Libya, Qatar, Ghana, Argentina, Bolivia, Brazil, Guatemala, Panama, India, United Kingdom, West Indies, South Africa, United Arab Emirates, Slovenia, Canada, Israel, United Kingdom, Romania, Argentina, Honduras, Russian Federation, R¿publique D¿mocratique du Congo, Switzerland, Dominican Republic, Greece, Saudi Arabia, and Portugal.

Lot, serial or model codes

Catalog Number: HE Cassette COVID 19 Lot Numbers: 2002198, 2003244, 2003285, 2003290, 2003291, 2003295, 2003308, 2004148, 2004158, 2005153, 2005154, 2005155, 2005213

510(k) numbers

not on file

PMA numbers

not on file

Product code

QKO

Firm FEI

3006048451

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy