Lower risk Medical device recall · FDA · Published February 18, 2022

NeuMoDx Cartridges May Give False SARS-CoV-2 Results - Recall

NeuMoDx recalls specific SARS-CoV-2 test cartridges that may cause false positive results, leading to incorrect patient management. Affected lots include 115424-115431.

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

🇺🇸 FDA recall #Z-1000-2022Medical device NeuMoDx ›

Lower-risk recall

Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients

Take action

Contact the company

Recalling firmNeuMoDx Molecular Inc1250 Eisenhower Pl · Ann Arbor, MI 48108-3281

✎ GovInfoNow plain-language explainer

NeuMoDx is recalling certain SARS-CoV-2 test cartridges that could give false positive results, which might lead to incorrect patient treatment. This recall affects specific lots of cartridges sold with certain test strips. Read more at govinfonow.com/recall/61135-neumodx-cartridges-may-give-false-sars-cov-2-results-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/61135-neumodx-cartridges-may-give-false-sars-cov-2-results-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1000-2022

Cite this page

“NeuMoDx Cartridges May Give False SARS-CoV-2 Results - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61135-neumodx-cartridges-may-give-false-sars-cov-2-results-recall. Based on FDA recall #Z-1000-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1000-2022%22&limit=1).

The FDA announced on Feb. 18, 2022, that NeuMoDx Molecular Inc is recalling NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems due to a potential for false positive SARS-CoV-2 results. The agency stated the hazard could lead to incorrect patient management.

How to tell if you have it

Brand: NeuMoDx
Product: NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems
UPC: 10814278020274
Lot Numbers: 115424, 115425, 115426, 115427, 115429, 115431
Assays: NeuMoDx SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900

The hazard

The recall addresses the potential for false positive results for SARS-CoV-2 in identified lots of cartridges when used with specific assays. The FDA stated this error could result in incorrect management of patients.

Context

GovInfoNow's records show NeuMoDx Molecular Inc has issued five other recalls since May 4, 2021. Other recent recalls of similar products include NeuMoDx Cartridges: Incorrect Label May Cause False Positives in PCR Tests (May 24, 2023), NeuMoDx SARS-CoV-2 Test Strips: Lot Number Mismatch Risk (May 15, 2023), and NeuMoDx Flu A-B/RSV/SARS-CoV-2 Test Strips May Give False Negatives (May 13, 2022). Other recent recalls of similar products include Changchun Wancheng Bio-Electron UTI Test Strips Recall: False Results Risk Inappropriate Treatment (Nov. 22, 2025), Vivoo Test Strips Recall: False Results Risk Inappropriate Medical Care (Nov. 22, 2025), and Fujirebio Lumipulse G pTau 217 Cartridges May Give False Alzheimer's Test Results (Dec. 11, 2025).

How to tell if you have this one

Check the lot numbers on the cartridge: 115424, 115425, 115426, 115427, 115429, or 115431. The cartridges are used with NeuMoDx SARS-CoV-2 Test Strip (REF 300800) or Flu A-B/RSV/SARS-CoV-2 Vantage Assay (REF 300900).

Brand
NeuMoDx
Product
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Cartridge Lot Number
Look for lot numbers 115424-115431 on the cartridge packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 8 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of OH, MO, VA, MI, MI, FL, MD, IA, NY, MO and the countries of Italy, Germany, Switzerland, Sweden, Netherlands, Finland, Spain, United Kingdom, Belgium, Austria, Hong Kong,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Iowa, Maryland, Michigan, Missouri, New York, Ohio, Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

Feb 18, 2022Firm started the recall
Apr 22, 2022FDA classified it Class II
May 4, 2022Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/61135-neumodx-cartridges-may-give-false-sars-cov-2-results-recall">NeuMoDx Cartridges May Give False SARS-CoV-2 Results - Recall (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-1000-2022 (February 18, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1000-2022 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.