Use caution Medical device recall · FDA · Published January 21, 2022

NeuMoDx Test Strip Recall: Contamination Risk and False Positives

NeuMoDx recalls specific lots of its Flu A-B/RSV/SARS-CoV-2 Vantage Test Strips due to contamination risks that may cause false positive SARS-CoV-2 results.

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

🇺🇸 FDA recall #Z-0738-2022Medical device NeuMoDx ›

Use caution until it’s fixed

A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

NeuMoDx Molecular Inc. is recalling a small quantity of its Flu A-B/RSV/SARS-CoV-2 Vantage Test Strips because the product was contaminated. This contamination creates an increased potential for false positive results when testing for SARS-CoV-2. The recall affects 102 boxes distributed in Florida, Maryland, Michigan, and New York. Read more at govinfonow.com/recall/61231-neumodx-flu-a-b-rsv-sars-cov-2-test-strips.

Source Summary by GovInfoNow · govinfonow.com/recall/61231-neumodx-flu-a-b-rsv-sars-cov-2-test-strips · Updated October 13, 2026 · FDA enforcement record: FDA #Z-0738-2022

Cite this page

“NeuMoDx Test Strip Recall: Contamination Risk and False Positives.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/61231-neumodx-flu-a-b-rsv-sars-cov-2-test-strips. Based on FDA recall #Z-0738-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0738-2022%22&limit=1).

The FDA announced on Jan. 21, 2022, that NeuMoDx Molecular Inc is recalling the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip due to a contamination risk that may cause false positive SARS-CoV-2 results. The agency classified the recall as Class II.

How to tell if you have it

Brand: NeuMoDx
Product: Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip
Ref #: 300900 (marketed under EUA202947)
Lot: 116305 S/L-02 (Sublot 02)
UDI: 10814278020830
Distribution: US Nationwide in FL, MD, MI, NY

The hazard

According to the FDA, a risk for product contamination was identified for the affected lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.

Context

GovInfoNow's records show NeuMoDx Molecular Inc has issued five other recalls since May 4, 2021. On May 24, 2023, the company recalled cartridges due to incorrect labels that may cause false positives in PCR tests. Other recent recalls of similar products include Changchun Wancheng Bio-Electron UTI Test Strips Recall (2025-11-22), Vivoo Test Strips Recall (2025-11-22), and Exploro Fertility Test Recall (2025-11-22).

How to tell if you have this one

Check if you have NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strips, Ref # 300900. Specifically look for Lot 116305 S/L-02 (Sublot 02) with UDI 10814278020830. The product is distributed in boxes of 6 assay strips in individual pouches, all labeled with the product name, reference number, lot number, and expiration date.

Brand
NeuMoDx
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Your Lot Number
Verify if your test strip box matches Lot 116305 S/L-02 (Sublot 02) with UDI 10814278020830.
Contact NeuMoDx for Instructions
Since the remedy is not stated in the record, contact NeuMoDx Molecular Inc. directly for specific instructions on how to handle or return the affected product.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

FDA distribution: “US Nationwide distribution in the states of FL, MD, MI, NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Maryland, Michigan, New York.

Recall timeline

FDA published this recall 54 days after the firm started it.

Jan 21, 2022Firm started the recall
Mar 8, 2022FDA classified it Class II
Mar 16, 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/61231-neumodx-flu-a-b-rsv-sars-cov-2-test-strips">NeuMoDx Test Strip Recall: Contamination Risk and False Positives (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-0738-2022 (January 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0738-2022 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.