Lower riskMedical device recall · FDA · Published May 24, 2023
NeuMoDx Cartridges: Incorrect Label May Cause False Positives in PCR Tests
NeuMoDx Molecular Inc recalls specific cartridges for PCR tests due to incorrect labeling that may cause false positive results. Affected lots include 117514, 117524, and 117528.
Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results
Take action
Contact the company
📍Recalling firmNeuMoDx Molecular Inc1250 Eisenhower Pl · Ann Arbor, MI 48108-3281
“NeuMoDx Cartridges: Incorrect Label May Cause False Positives in PCR Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58087-neumodx-cartridges-incorrect-label-may-cause-false-positives-in-pcr. Based on FDA recall #Z-2255-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2255-2023%22&limit=1).
The FDA announced on May 24, 2023, that NeuMoDx Molecular Inc is recalling NeuMoDx Cartridges due to a label encroachment hazard. This defect increases the risk of false positive results in nucleic acid testing.
How to tell if you have it
Brand: NeuMoDx
Product: NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288
UPC: 10814278020274
Lot Numbers: 117514, 117524, and 117528
The hazard
The top label on some cartridges may have been incorrectly applied during manufacturing, encroaching into the PCR region. This misplaced label can interfere with the module's optics performance, thereby increasing the risk for false positive results.
Context
GovInfoNow's records show NeuMoDx Molecular Inc has issued five other recalls since May 4, 2021. Recent brand recalls include a May 15, 2023, recall of SARS-CoV-2 Test Strips for lot number mismatch risks and a Feb. 18, 2022, recall of cartridges that may give false SARS-CoV-2 results. Other recent recalls of similar products include Medtronic HR-ACT Cartridges Recall (Oct. 20, 2025) and Inpeco FlexLab FLX-217-40 (Oct. 30, 2025).
How to tell if you have this one
Check the lot number on the cartridge packaging. Affected lots are 117514, 117524, and 117528. These cartridges are used with NeuMoDx 288 and 96 Molecular Systems.
Brand
NeuMoDx
Product
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Cartridge Lot Number
Look for lot numbers 117514, 117524, or 117528 on the cartridge packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New York, Michigan, Pennsylvania; and OUS (Foreign) to countries of: AT, BE, CH, DE, ES, FI, FR, GB, IT, LV, PL, RO, SE” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Kansas, Michigan, New York, Ohio, Pennsylvania, Texas.
Recall timeline
FDA published this recall 3 months 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.
Are there any safety risks from using these cartridges?
The hazard is low risk as it only affects test results, not physical safety. False positives may cause unnecessary concerns but do not pose a direct health risk.
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-2255-2023 (May 24, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2255-2023 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.