Recall Z-0510-2021 ยท QMN Covid-19 Multi-Analyte Antigen Device
VEO DIAGNOSTICS, LLC
ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
| Date | Nov 5, 2020 |
| Status | Terminated |
| Reason | Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests |
| Root cause | Device Design |
| Action | Plexense issued NOTICE IMPORTANT PRODUCT WITHDRAWAL dated 11/5/20, stating reason for withdrawal, health risk and action take: clinical decisions. " If this test has been used to make clinical decisions, evaluate each patients clinical presentation and medical history, whether prior test results generated using this test may have been incorrect, and whether the patient should be retested using an FDA-authorized test. " Complete the Customer Response Form that accompanies this letter and return it to VEO Diagnostics, Plexenses US distributor, to confirm that you have received and understand th |
| Quantity | 15 kits |
| Distribution | US Nationwide distribution including in the states of IA, PA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.