NeuMoDx Cartridge Recall: False Positive Results Risk
NeuMoDx Molecular Inc recalls specific model cartridges for in vitro diagnostics due to potential false positive results with certain assays. Affected lots: 106629-106632.
Lower-risk recall
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Contact the company
What happened, in plain English
NeuMoDx Molecular Inc is recalling specific cartridges for their 288 and 96 Molecular Systems. These cartridges could give false positive results when used with certain tests, which might lead to incorrect health conclusions. Read more at govinfonow.com/recall/62607-neumodx-cartridge-recall-false-positive-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62607-neumodx-cartridge-recall-false-positive-results-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1978-2021
Cite this page
“NeuMoDx Cartridge Recall: False Positive Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62607-neumodx-cartridge-recall-false-positive-results-risk. Based on FDA recall #Z-1978-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1978-2021%22&limit=1).
Why it’s dangerous
The cartridges may produce false positive results when used with specific diagnostic assays. This could lead to incorrect health conclusions if the tests are used for medical purposes. The risk is limited to certain lots and specific assay combinations.
Who’s affected
Users of NeuMoDx 288 and 96 Molecular Systems with specific cartridge lots (106629-106632) are affected. Laboratory professionals using these cartridges for in vitro diagnostics are most at risk.
How to tell if you have this one
Check if your NeuMoDx 288 or 96 Molecular System uses cartridges labeled Model Number 100100 with lot numbers 106629 through 106632.
- Brand
NeuMoDx- Product
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100- Category
Medical device
What to do — step by step
Check Cartridge Lot Number
Look for the lot number on the cartridge packaging; affected lots are 106629 to 106632.
How this recall unfolded
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1978-2021 (May 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1978-2021 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.