GeneXpert® XPRS4PLEX-10Recalls & reported problems
Cepheid · Xpert Xpress CoV-2/Flu/RSV plus · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07332940008604), received between Dec 4, 2025 and Dec 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025False Negative Result; False Negative Result
US CUSTOMER CONTACTED CEPHEID TO REPORT A QUESTIONABLE NEGATIVE RESULT FOR FLU B USING THE XPERT XPRESS COV-2/FLU/RSV PLUS ASSAY. PATIENT WAS TESTED USING XPERT XPRESS COV-2/FLU/RSV PLUS LOT 68119 WHICH RESULTED IN SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE. SAMPLE WAS PROCESSED PER IFU. THIS RESULT WAS REPORTED TO THE PHYSICIAN. TWO NASOPHARYNGEAL SWABS WERE COLLECTED FOR THIS PATIENT AT THE SAME TIME. WHEN RESULTS OF XPERT XPRESS COV-2/FLU/RSV PLUS IVD WERE REPORTED AS NEGATIVE FOR ALL TARGETS, THE CUSTOMER QUESTIONED THE FLU RESULTS SINCE THEY HIGHLY SUSPECTED THE PATIENT HAD THE FLU AS THE PATIENT PRESENTED WITH A COUGH AND FLU-LIKE SYMPTOMS. THEY USED THE SECOND SWAB TO TEST WITH THEIR SOFIA QUIDEL RAPID FLU A/FLU B TEST. SAMPLES WERE STORED AT ROOM TEMPERATURE PRIOR TO TESTING. SOFIA QUIDEL RAPID FLU A/FLU B TEST RESULTED IN FLU A NEGATIVE, FLU B POSITIVE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE LOT NUMBER FOR SOFIA QUIDEL IS UNKNOWN. THERE WERE NO KNOWN UNDERLYING CONDITIONS AND NO KNOWN IMPACT ON THE PATIENT DUE TO THE DISCREPANCY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23720161 ↗
Other Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents devices
- BioFire® Respiratory Panel 2.1 423742Biofire Diagnostics, LLC · Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents3 recalls4 reports
- Panther Fusion® KIT, SARS/FLU A/B/RSV REAG CARTRDG, 96T, FUS, IVDHologic, Inc. · Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents1 recall7 reports
- QIAstat-Dx® Respiratory Panel Plus V1QIAGEN GmbH · Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents1 recall0 reports
- DASH® SARS-CoV-2 & Flu A/B Test Kit SG-0006Nuclein, LLC · Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents1 recall0 reports
- BD Respiratory Viral Panel for BD MAX™ System 445373Becton, Dickinson And Company · Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents8 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page