FDA Device recall Z-1450-2022
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
- FDA Device
- Class II
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip by Lumiradx, citing modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1450-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-24 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Lumiradx |
| Distribution | AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, WI |
Product
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Reason
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Identifiers
| code_info | No UDI codes. Catalog No. L017000109024. Lot No. 5000599 (Exp. 08-Mar-2022), 5000602 (Exp. 10-Mar-2022), 5000612 (Exp.…No UDI codes. Catalog No. L017000109024. Lot No. 5000599 (Exp. 08-Mar-2022), 5000602 (Exp. 10-Mar-2022), 5000612 (Exp. 23-Mar-2022), 5000613 (Exp. 24-Mar-2022), 5000614 (Exp. 25-Mar-2022), 5000617 (Exp. 16-Apr-2022), and 5000676 (Exp. 25-Aug-2022). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1450-2022%22
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