Lower riskMedical device recall · FDA · Published May 13, 2022
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Test Strips May Give False Negatives
NeuMoDx recalls Flu A-B/RSV/SARS-CoV-2 Vantage Test Strips (Model 300900) due to potential false negatives in certain samples, which could lead to undetected infections and delayed treatment.
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
Take action
Contact the company
📍Recalling firmNeuMoDx Molecular Inc1250 Eisenhower Pl · Ann Arbor, MI 48108-3281
✎ GovInfoNow plain-language explainer
NeuMoDx is recalling Flu A-B/RSV/SARS-CoV-2 Vantage Test Strips (Model 300900) because they might give false negative results for some infections. This could mean people don't know they're infected and might spread illness or delay treatment. Read more at govinfonow.com/recall/60705-neumodx-flu-a-b-rsv-sars-cov-2-test-strips.
“NeuMoDx Flu A-B/RSV/SARS-CoV-2 Test Strips May Give False Negatives.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60705-neumodx-flu-a-b-rsv-sars-cov-2-test-strips. Based on FDA recall #Z-1251-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1251-2022%22&limit=1).
The FDA announced on May 13, 2022, that NeuMoDx Molecular Inc is recalling the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900. The agency cited a potential for reduced analytical sensitivity that may lead to false negative results.
How to tell if you have it
Brand: NeuMoDx
Product: NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip
Model No.: 300900
UDI-DI (GTIN): 10814278020830
Lot numbers: 111915 - 117508
The hazard
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
Context
GovInfoNow's records show NeuMoDx Molecular Inc has issued five other recalls since May 4, 2021. Other recent recalls of similar products include Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), S. Typhi/Para Ty: False Test Results Risk from Unapproved Diagnostic Strips (Nov. 22, 2025), and Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025).
How to tell if you have this one
Check for the model number 300900 on the test strip packaging. The product was sold with lot numbers 111915 to 117508.
Brand
NeuMoDx
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Test Strip Model
Look for the model number 300900 on the test strip packaging to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed in 8 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Maryland, Michigan, New Mexico, New York, Pennsylvania, Tennessee, Virginia.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1251-2022 (May 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1251-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.