Recall Z-2409-2021 ยท QKO Reagent, Coronavirus Serological
Versea Diagnostics LLC
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency
| Date | Jul 27, 2021 |
| Status | Terminated |
| Reason | Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization. |
| Root cause | Nonconforming Material/Component |
| Action | Versea Diagnostics, LLC began distributing their "URGENT MEDICAL DEVICE RECALL" notices dated 7/14/2021 to their direct consignee on 7/27/2021 by email. The notices instructed the customers immediately discontinue use of these test and quarantine, discard, return, or destroy any unused tests. Confirm any results from these tests using a different EUA authorized test. Discontinue the use of these products if you do not hold the required CLLIA status. Acknowledge your receipt of this notice by completing the attached Response Form, scanning and emailing the completed form to: compliance@verse |
| Quantity | 563,290 in total |
| Distribution | US Nationwide Distribution: AL, AZ, CA, CO, CT, FL, GA, IL, KS, OH, OK, MA, MD, MI, NC, NJ, NY, PA, SC, TX, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.