Stop using nowMedical device recall · FDA · Published February 3, 2021
LumiraD: Coronavirus antigen test system with false positives - Stop using now
LumiraDx recalls coronavirus antigen test systems that gave false positives due to failed QC testing. Stop using these products immediately to avoid inaccurate results.
“LumiraD: Coronavirus antigen test system with false positives - Stop using now.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63318-lumirad-coronavirus-antigen-test-system-with-false-positives-stop-using. Based on FDA recall #Z-1312-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1312-2021%22&limit=1).
The FDA announced on Feb. 3, 2021, that LumiraDx voluntarily recalled two lots of its Coronavirus antigen detection test system due to false positives from failed quality control testing. The agency issued recall number Z-1312-2021 for the Class II device distributed nationwide in the U.S.
How to tell if you have it
Brand: LumiraDx
Product: Coronavirus antigen detection test system
Catalog #: L001000330001
Quantity: 2186 devices
The hazard
Two lots of test strips failed quality control testing using blank buffer due to false positives, according to the FDA. The device is intended for qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples.
Context
GovInfoNow's records show LumiraDx has had four other recalls since Jan. 11, 2021, including a April 25, 2023 recall for SteriPack Swabs that may break and a Sept. 23, 2022 recall involving incorrect product assignment for SARS-CoV-2 Antigen Kits. Other recent recalls of similar products include the LH One Step Ovulation Test Device Recall on Nov. 22, 2025, and the Meridian Bioscience Revogene C. difficile Test Recall on Dec. 5, 2025.
How to tell if you have this one
The recalled products are LumiraDx coronavirus antigen test systems with catalog number L001000330001. They were intended for use by healthcare providers testing nasal swabs from suspected COVID-19 patients.
Brand
LumiraDx
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop using it now
Immediately stop using the recalled test systems to avoid false positive results.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1312-2021 (February 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1312-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.