Lower risk Medical device recall · FDA · Published January 11, 2021

LumiraDx SARS-CoV-2 Ag Test Strips: False Positive Risk

LumiraDx recalls specific lots of SARS-CoV-2 antigen test strips due to potential false positives, which could lead to unnecessary treatment or quarantine. Affected lots include 5000269, 5000280, 5000306, 5000323, 6000142, and 6000100.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1132-2021Medical device LumiraDx ›

Lower-risk 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.

Take action

Contact the company

Recalling firmLumiraDx221 Crescent St · Waltham, MA 02453-3475

✎ GovInfoNow plain-language explainer

LumiraDx is recalling specific lots of SARS-CoV-2 antigen test strips that may produce false positive results. This could lead to unnecessary treatment or quarantine for people who test positive but are actually healthy. Read more at govinfonow.com/recall/63437-lumiradx-sars-cov-2-ag-test-strips-false-positive-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63437-lumiradx-sars-cov-2-ag-test-strips-false-positive-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1132-2021

Cite this page

“LumiraDx SARS-CoV-2 Ag Test Strips: False Positive Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63437-lumiradx-sars-cov-2-ag-test-strips-false-positive-risk. Based on FDA recall #Z-1132-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1132-2021%22&limit=1).

The FDA announced on Jan. 11, 2021, that LumiraDx is recalling its SARS-CoV-2 Ag Test Strip Kit US EUA due to potential false positive results. The agency stated the hazard could lead to unnecessary treatment or quarantine for patients.

How to tell if you have it

Brand: LumiraDx
Product: LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN)
Catalog #: L016000109048
Lot codes: 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261), 5000323 (GM2000354), 6000142 (GM2000296), 6000100 (GM2000322)
Distribution: Worldwide, including US states CA, GA, PA, SD and countries Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom

The hazard

The FDA reported 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.

Context

GovInfoNow's records show LumiraDx has had four other recalls since Feb. 3, 2021, including a April 25, 2023 recall for SteriPack Swabs that may break and a Sept. 23, 2022 recall for SARS-CoV-2 Antigen Kits involving incorrect product assignment. Other recent recalls of similar products include Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), S. Typhi/Para Ty false results risk (Nov. 22, 2025), and Vivoo Test Strips Recall (Nov. 22, 2025).

How to tell if you have this one

Check the lot numbers on the test strips: 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261), 5000323 (GM2000354), 6000142 (GM2000296), and 6000100 (GM2000322). The product is part of the LumiraDx Platform for professional use.

Brand
LumiraDx
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Look for the lot numbers 5000269, 5000280, 5000306, 5000323, 6000142, or 6000100 on the test strips.

Where it went and when

Where it was distributed

Distributed in 4 states, and outside the U.S.

FDA distribution: “Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Georgia, Pennsylvania, South Dakota.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Jan 11, 2021Firm started the recall
Feb 17, 2021FDA classified it Class II
Feb 24, 2021Published in FDA’s Enforcement Report
Dec 3, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these test strips?

The recall does not require stopping use immediately; check the lot numbers to see if your strips are affected.

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Link to this recall

<a href="https://govinfonow.com/recall/63437-lumiradx-sars-cov-2-ag-test-strips-false-positive-risk">LumiraDx SARS-CoV-2 Ag Test Strips: False Positive Risk (GovInfoNow)</a>

Where this comes from

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-1132-2021 (January 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1132-2021 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.