Recall Z-0135-2023 ยท QKP Coronavirus Antigen Detection Test System.
LumiraDx
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
| Date | Oct 26, 2022 (initiated Sep 23, 2022) |
| Status | Terminated |
| Reason | Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC |
| Root cause | Error in labeling |
| Action | LumiraDx issued Urgent Product Recall Notice and were provided with an attestation form to document product destruction at their facility via email on 23 September 2022. Letter states reason for recall, health risk and action to take: Immediately stop using the affected lots of LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls. " Remove from your stock any remaining affected kits of LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls as listed in Table 1. " Ensure any of the affected SARS-CoV-2 Antigen (Ag) Liquid Quality Controls are removed from your inventory are destroyed (not |
| Quantity | 83 kits |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.