LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA — Class II medical device recall Z-1132-2021
Terminated recall by LumiraDx, reported 2021-02-24, distributed in CA, GA, PA, SD. Observations of potential false positive results in the specified lots. Use of these test strips may result in
| Recall number | Z-1132-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LumiraDx, Waltham, MA, United States |
| Recall initiated | 2021-01-11 |
| Classified | 2021-02-17 |
| Reported by FDA | 2021-02-24 |
| Terminated | 2021-12-03 |
| Distributed | CA, GA, PA, SD |
| Countries outside the US | AT, DE, ES, GB, IE, IT, LB, NL, SI |
| Lot numbers | 5000269 |
| Model numbers | L016000109048 |
Product
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
Reason for recall
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.
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-1132-2021. 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.