cobas® WNV (96 tests) 07001061190Recalls & reported problems
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00875197004960), received between Sep 19, 2025 and Sep 19, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2 reports).
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
Most reported problems
Device problems
- False Positive Result2
- Incorrect, Inadequate or Imprecise Result or Readings2
- Output Problem2
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025False Positive Result; False Positive Result
THE INITIAL REPORTER ALLEGED A DISCREPANT RESULT WITH THE KIT COBAS 6800/8800 WNV 96T IVD ASSAY DURING PARTICIPATION IN THE INSTAND RINGVERSUCH 391 WEST NILE VIRUS (WNV) PANEL. THE CUSTOMER REPORTED THAT ONE SAMPLE, IDENTIFIED AS (B)(6), GENERATED A REACTIVE RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 31.82, WHILE THE EXPECTED RESULT PROVIDED BY THE PANEL WAS NEGATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23100572 ↗MalfunctionSep 19, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WHEN USING THE KIT COBAS 6800/8800 WNV 96T IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THE CUSTOMER REPORTED THAT A POOL OF 8 SAMPLES WAS REACTIVE FOR WEST NILE VIRUS (WNV). UPON RESOLUTION TESTING, THE POOL WAS REACTIVE WITH A CYCLE THRESHOLD (CT) VALUE OF 38. AN IN-HOUSE POLYMERASE CHAIN REACTION (PCR) TEST PERFORMED ON THE SAME SAMPLE WAS NON-REACTIVE. THE DONATION ASSOCIATED WITH THE SAMPLE WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23100162 ↗MalfunctionSep 19, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE INITIAL REPORTER ALLEGED THEY OBSERVED INVALID RESULTS USING THE KIT COBAS 6800/8800 WNV 96T IVD ASSAY ON THE COBAS 6800 SYSTEM. THE CUSTOMER USED WEST NILE VIRUS (WNV) CONTROL MATERIAL FROM HELVETICA HEALTH CARE (HHC), CONCENTRATED AT 10,000 COPIES/ML, WHICH THEY DILUTED TO THE DESIRED CONCENTRATION USING FRESH FROZEN PLASMA (FFP). THE CUSTOMER REPORTED NON-REACTIVE RESULTS FOR SOME DILUTIONS OF THE WNV QUALITY CONTROL MATERIAL, WHICH WERE EXPECTED TO BE REACTIVE AS THEY WERE ABOVE THE ASSAY'S LIMIT OF DETECTION (LOD) OF 12.9 COPIES/ML (LINEAGE 1). THE CUSTOMER DID NOT ACCEPT AN INITIAL EXPLANATION THAT THESE RESULTS WERE NEAR THE LOD OF THE ASSAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097845 ↗
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
- 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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