Recall Z-2407-2021 ยท QKP Coronavirus Antigen Detection Test System.
Versea Diagnostics LLC
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological r
| 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.