FDA Device recall Z-1312-2021
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SA…
- FDA Device
- Class II
- terminated
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class II recall of Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SA… by Lumiradx, citing two lots of test strips failed QC testing using blank buffer due to false positives.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1312-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-03 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Lumiradx |
| Distribution | US |
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
Two lots of test strips failed QC testing using blank buffer due to false positives.
Identifiers
| code_info | catalog #: L001000330001 |
|---|
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-1312-2021%22
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