LumiraDx SARS-CoV-2 Antibody — Class II medical device recall Z-1451-2022
Terminated recall by LumiraDx, reported 2022-07-27, distributed in AR, CA, FL, MA, MD, NC, NJ, NV…. Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA
| Recall number | Z-1451-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LumiraDx, Waltham, MA, United States |
| Recall initiated | 2022-06-24 |
| Classified | 2022-07-21 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2024-05-10 |
| Distributed | AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, WI |
| Quantity | 99 units |
| Lot numbers | 2002201428 |
| Model numbers | L017080109002 |
| Expiration dates | 2022-09-01 |
Product
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Reason for recall
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1451-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.