Recall Z-1450-2022 ยท QKO Reagent, Coronavirus Serological
LumiraDx
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
| Date | Jul 22, 2022 (initiated Jun 24, 2022) |
| Status | Terminated |
| Reason | Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. |
| Root cause | Under Investigation by firm |
| Action | The firm distributed an email titled "URGENT: MEDICAL DEVICE RECALL" dated 06/24/2022 to customers informing them of the removal of LumiraDx SARS-CoV-2 Antibody (Ab) Test Strips and Liquid Quality Control due to design changes implemented outside the approved EUA. The firm asks that customers immediately stop use of recalled devices and remove any remaining tests from stock. Any devices in stock are to be destroyed. Customers are asked to complete the provided Customer Destruction and Attestation form to indicate how much product is in stock and destroyed by customers. Forms are to be returned |
| Quantity | 635 units |
| Distribution | Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.