NeuMoDx SARS-CoV-2 Test Strip 300800Recalls & reported problems
Neumodx Molecular, Inc. · Class N
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This NeuMoDx SARS-CoV-2 test strip is a single-use reagent strip for a molecular testing system. The 38 reports mostly describe test results that did not match results from another method, with 15 injuries and 23 malfunctions reported and no deaths. One open recall, started in May 2023, concerns a lot number mismatch between the strip packaging and the barcode label the instrument reads.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10814278021264), received between Dec 15, 2020 and Oct 3, 2023 — classified as 15 injuries, 23 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (1 report).
1 FDA recall record name this device's identifier, 1 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.
Reports received per month
Recalls naming this device
- May 15, 2023Class IIIOpen, Classified
Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.
Z-2093-2023 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported problems
Device problems
- No Apparent Adverse Event38
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- Insufficient Information7
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2023No Apparent Adverse Event; No Apparent Adverse Event
DISCREPANT RESULTS FOR SARS COV-2 TARGET WITH NEUMODX SARS-COV-2 TEST STRIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17861952 ↗MalfunctionMar 13, 2023No Apparent Adverse Event; No Apparent Adverse Event
DISCREPANT RESULTS FOR SARS COV-2 TARGET WITH NEUMODX SARS-COV-2 TEST STRIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16531190 ↗MalfunctionMar 6, 2023No Apparent Adverse Event; No Apparent Adverse Event
DISCREPANT RESULTS FOR SARS COV-2 TARGET WITH NEUMODX SARS-COV-2 TEST STRIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16491821 ↗MalfunctionFeb 3, 2023No Apparent Adverse Event; No Apparent Adverse Event
DISCREPANT RESULTS FOR SARS COV-2 TARGET WITH NEUMODX SARS-COV-2 TEST STRIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16298777 ↗MalfunctionJan 27, 2023No Apparent Adverse Event; No Apparent Adverse Event
DISCREPANT RESULTS FOR SARS COV-2 TARGET WITH NEUMODX SARS-COV-2 TEST STRIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16253899 ↗MalfunctionJan 20, 2023False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
DISCREPANT RESULTS FOR SARS COV-2 TARGET WITH NEUMODX SARS-COV-2 TEST STRIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16218384 ↗MalfunctionOct 13, 2022No Apparent Adverse Event; No Apparent Adverse Event
RESULTS FOR NEUMODX SARS COV2 TEST STRIP WAS DISCREPANT WITH ANOTHER METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15597227 ↗MalfunctionAug 12, 2022No Apparent Adverse Event; No Apparent Adverse Event
RESULTS FOR NEUMODX SARS COV-2 ON THE NEUMODX 288 MOLECULAR SYSTEM WERE DISCREPANT WITH ANOTHER METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15221563 ↗MalfunctionAug 9, 2022No Apparent Adverse Event; No Apparent Adverse Event
RESULTS FOR NEUMODX SARS COV-2 ON THE NEUMODX 288 OR 96 MOLECULAR SYSTEM WERE DISCREPANT WITH ANOTHER METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15196284 ↗MalfunctionAug 5, 2022No Apparent Adverse Event; No Apparent Adverse Event
SUSPECTED FALSE POSITIVE FOR NEUMODX SARS-COV-2 TEST STRIPS ON THE NEUMODX 96 MOLECULAR SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15178875 ↗MalfunctionJun 30, 2022No Apparent Adverse Event; No Apparent Adverse Event
SUSPECTED FALSE POSITIVE RESULT FOR NEUMODX SARS-COV-2 ON THE NEUMODX 96 MOLECULAR SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14877210 ↗MalfunctionMay 27, 2022No Apparent Adverse Event; No Apparent Adverse Event
RESULTS FOR NEUMODX SARS-COV-2 ON THE NEUMODX 288 MOLECULAR SYSTEM WERE DISCREPANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14525733 ↗MalfunctionFeb 18, 2022No Apparent Adverse Event; No Apparent Adverse Event
RESULTS FOR THE NEUMODX SARS-COV-2 TEST STRIP ON THE NEUMODX 288 MOLECULAR SYSTEM WERE DISCREPANT WITH ANOTHER METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13558540 ↗MalfunctionFeb 18, 2022No Apparent Adverse Event; No Apparent Adverse Event
RESULTS WHICH WERE POSITIVE FOR THE NEUMODX SARS-COV-2 TEST STRIP ON THE NEUMODX 288 MOLECULAR SYSTEM WERE DISCREPANT WITH ANOTHER METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13558537 ↗MalfunctionFeb 18, 2022No Apparent Adverse Event; No Apparent Adverse Event
FALSE POSITIVE RESULTS FOR NEUMODX SARS-COV-2 TEST STRIP ON THE NEUMODX 288 MOLECULAR SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13558536 ↗MalfunctionFeb 18, 2022No Apparent Adverse Event; No Apparent Adverse Event
RESULTS FOR THE NEUMODX SARS-COV-2 TEST STRIP ON THE NEUMODX 288 MOLECULAR SYSTEM WERE DISCREPANT WITH ANOTHER METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13558535 ↗MalfunctionFeb 18, 2022No Apparent Adverse Event; No Apparent Adverse Event
RESULTS FOR THE NEUMODX SARS-COV-2 TEST STRIP ON THE NEUMODX 96 MOLECULAR SYSTEM WERE DISCREPANT WITH ANOTHER METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13558534 ↗MalfunctionFeb 18, 2022No Apparent Adverse Event; No Apparent Adverse Event
FALSE POSITIVE RESULT FOR THE NEUMODX SARS-COV-2 TEST STRIP ON THE NEUMODX 288 MOLECULAR SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13558533 ↗MalfunctionFeb 18, 2022No Apparent Adverse Event; No Apparent Adverse Event
RESULTS FOR THE NEUMODX SARS-COV-2 TEST STRIP ON THE NEUMODX 96 MOLECULAR SYSTEM WERE DISCREPANT WITH ANOTHER METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13558532 ↗MalfunctionFeb 18, 2022No Apparent Adverse Event; No Apparent Adverse Event
RESULTS WHICH WERE POSITIVE FOR THE NEUMODX SARS-COV-2 TEST STRIP ON THE NEUMODX 288 MOLECULAR SYSTEM WERE DISCREPANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13558531 ↗MalfunctionJan 27, 2022No Apparent Adverse Event; No Apparent Adverse Event
RESULTS WHICH WERE POSITIVE FOR THE NEUMODX SARS-COV-2 TEST STRIP ON THE ON THE NEUMODX 288 MOLECULAR SYSTEM WERE DISCREPANT WITH ANOTHER METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13372142 ↗InjuryJan 13, 2022No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER REPORTED DISCREPANT RESULT WITH THE NEUMODX SARS-COV-2 ON THE NEUMODX 96 MOLECULAR SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13255517 ↗InjuryJan 12, 2022No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER REPORTED RESULTS WITH THE NEUMODX SARS-COV-2 ON THE NEUMODX 96 MOLECULAR SYSTEM WAS DISCREPANT WITH ANOTHER METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13239610 ↗InjuryJan 6, 2022No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER REPORTED DISCREPANT RESULTS WITH THE NEUMODX SARS-COV-2 ON THE NEUMODX 96 MOLECULAR SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13178671 ↗InjuryDec 29, 2021No Apparent Adverse Event; No Apparent Adverse Event
RESULTS FOR THE NEUMODX SARS-COV-2 ON THE NEUMODX 96 MOLECULAR SYSTEM WERE DISCREPANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13111821 ↗
Other Reagents, 2019-Novel Coronavirus Nucleic Acid devices
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- Lyra CoronavirusDiagnostic Hybrids, Inc. · Reagents, 2019-novel coronavirus nucleic acid403 reports
- Solana SARS-CoV-2 Assay CoronavirusDiagnostic Hybrids, Inc. · Reagents, 2019-novel coronavirus nucleic acid328 reports
- Alinity m 09N79-096Abbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid2 recalls179 reports
- Alinity m 09N78-03EAbbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid3 recalls0 reports
- BioFire® Respiratory Panel 2.1 EUA 423738Biofire Diagnostics, LLC · Reagents, 2019-Novel Coronavirus Nucleic Acid3 recalls0 reports
- Alinity m 09N79-05DAbbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid2 recalls0 reports
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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