NeuMoDxTM Cartridge 100100Recalls & reported problems
Neumodx Molecular, Inc. · NeuMoDx Cartridge · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10814278020274), received between May 12, 2021 and May 12, 2021 — classified as 5 malfunctions.
3 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- May 24, 2023Class IIOpen, Classified
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
Z-2255-2023 · Root cause: Employee error · Recall details · FDA record ↗
- Feb 18, 2022Class IIOpen, Classified
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
Z-1000-2022 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
- May 4, 2021Class IITerminated
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Z-1978-2021 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Most reported problems
Device problems
- No Apparent Adverse Event5
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2021No Apparent Adverse Event; No Apparent Adverse Event
NEGATIVE CONTROL FOR SARS-COV-2 WAS POSITIVE ON THE NEUMODX 288 MOLECULAR SYSTEM. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11815550 ↗MalfunctionMay 12, 2021No Apparent Adverse Event; No Apparent Adverse Event
FALSE POSITIVE RESULTS FOR NEUMODX SARS-COV-2 ON THE NEUMODX 288 MOLECULAR SYSTEM.
Patient problems: Insufficient Information
MAUDE report 11815533 ↗MalfunctionMay 12, 2021No Apparent Adverse Event; No Apparent Adverse Event
RESULTS WITH NEUMODX SARS-COV-2 ON THE NEUMODX 288 MOLECULAR SYSTEM WERE DISCREPANT WITH ANOTHER METHOD.
Patient problems: Insufficient Information
MAUDE report 11815528 ↗MalfunctionMay 12, 2021No Apparent Adverse Event; No Apparent Adverse Event
RESULTS OF NEUMODX SARS-COV-2 ON THE NEUMODX 288 MOLECULAR SYSTEM WERE DISCREPANT WITH ANOTHER METHOD.
Patient problems: Insufficient Information
MAUDE report 11815506 ↗MalfunctionMay 12, 2021No Apparent Adverse Event; No Apparent Adverse Event
RESULTS OF NEUMODX SARS-COV-2 TEST ON THE NEUMODX 288 MOLECULAR SYSTEM WAS DISCREPANT WITH ANOTHER METHOD.
Patient problems: Insufficient Information
MAUDE report 11815457 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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