Coronavirus antigen detection test system — Class II medical device recall Z-1312-2021
Terminated recall by LumiraDx, reported 2021-04-07, distributed nationwide. Two lots of test strips failed QC testing using blank buffer due to false positives.
| Recall number | Z-1312-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LumiraDx, Waltham, MA, United States |
| Recall initiated | 2021-02-03 |
| Classified | 2021-03-26 |
| Reported by FDA | 2021-04-07 |
| Terminated | 2022-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 2,186 devices |
| Model numbers | L001000330001 |
Product
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset.
Reason for recall
Two lots of test strips failed QC testing using blank buffer due to false positives.
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-1312-2021. 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.