Recall Z-1126-2021 ยท QKO Reagent, Coronavirus Serological
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.
| Date | Jan 29, 2021 |
| Status | Terminated |
| 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 t |
| 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 countri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.