cobas&#x00AE WNV (480 tests) 07001070190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00875197004977), received between Sep 16, 2025 and Sep 19, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE KIT COBAS 6800/8800 WNV 480T IVD ASSAY ON THE COBAS 8800 SYSTEM. THE ALLEGATION INVOLVES MULTIPLE WEST NILE VIRUS (WNV) SAMPLES THAT INITIALLY TESTED REACTIVE BUT TURNED NON-REACTIVE UPON RETESTING. DATA PROVIDED BY THE CUSTOMER SHOWED WEAK WNV POLYMERASE CHAIN REACTION (PCR) CURVES WITH LATE CYCLE THRESHOLD (CT) VALUES, WHILE THE INTERNAL CONTROL (IC) CURVES WERE ROBUST. SPECIFIC EXAMPLES INCLUDE: - SAMPLE ID (B)(6): WNV CURVE 39.11, IC CURVE 34.76. - SAMPLE ID (B)(6): WNV CURVE 39.53, IC CURVE 35.78. - SAMPLE ID (B)(6): WNV CURVE 38.47, IC CURVE 34.62. - SAMPLE ID (B)(6): WNV CURVE 39.19, IC CURVE 35.1. - SAMPLE ID (B)(6): WNV CURVE 39.35, IC CURVE 35.15. THE RESULTS WERE QUESTIONED DUE TO THE OBSERVED VARIABILITY BETWEEN REACTIVE AND NON-REACTIVE OUTCOMES FOR THE SAME SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099626 ↗
• MalfunctionSep 18, 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 AN INCREASE IN UNEXPECTED REACTIVE RESULTS WHEN USING THE KIT COBAS 6800/8800 WNV 480T IVD ASSAY ON THE COBAS 8800 INSTRUMENT DURING THE MONTH OF (B)(6) 2022. THE CUSTOMER¿S WORKFLOW INVOLVES TESTING SAMPLES IN POOLS OF 6 (B)(6). IF A POOL GENERATES A REACTIVE RESULT FOR WEST NILE VIRUS (WNV), THE SAMPLES ARE TESTED IN RESOLUTION, AND THE RESULTS ARE NON-REACTIVE. THE DONATIONS ASSOCIATED WITH THESE RESULTS WERE NOT REJECTED. THE DATA PROVIDED BY THE CUSTOMER INCLUDED THE FOLLOWING REACTIVE SAMPLES WITH THEIR RESPECTIVE CYCLE THRESHOLD (CT) VALUES: (B)(6) (33.5), (B)(6) (36.7), (B)(6) (29.4), (B)(6) (28.0), (B)(6) (26.0), (B)(6) (25.8), (B)(6) (39.9), (B)(6) (38.3), (B)(6) (27.6), (B)(6) (24.4), (B)(6) (27.9), (B)(6) (34.2), (B)(6) (33.8), (B)(6) (38.7), AND (B)(6) (39.1). THE SPECIFIC SAMPLE IDS ALLEGED TO BE FALSE REACTIVE WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085571 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE KIT COBAS 6800/8800 WNV 480T IVD ON THE COBAS 8800 INSTRUMENT. THE ALLEGATION INVOLVES A POOLED SAMPLE THAT GENERATED A REACTIVE RESULT FOR WEST NILE VIRUS (WNV). SUBSEQUENT INDIVIDUAL DONOR TESTING (IDT) OF ALL SAMPLES WITHIN THE POOL GENERATED NON-REACTIVE RESULTS. THE NON-REACTIVE RESULTS WERE REPORTED. THE CUSTOMER DOES NOT KNOW IF THE BLOOD WAS USED. THE SAMPLES IN THE ALLEGED POOL WERE COLLECTED BETWEEN (B)(6) 2021 AND (B)(6) 2021, WITH TESTING PERFORMED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083405 ↗
• MalfunctionSep 18, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR A SINGLE SAMPLE ID TESTED THREE TIMES WITH THE KIT COBAS 6800/8800 WNV 480T IVD ASSAY ON THE COBAS 8800 SYSTEM. FOR SAMPLE ID: (B)(6), ON (B)(6) 2025 THE SAMPLE TESTED REACTIVE ON INSTRUMENT 5160. FOR SAMPLE ID: (B)(6), ON (B)(6) 2025 THE SAMPLE TESTED NON-REACTIVE ON INSTRUMENT 5159. FOR SAMPLE ID: (B)(6), ON (B)(6) 2025 THE SAMPLE TESTED NON-REACTIVE ON INSTRUMENT 5158.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083048 ↗
• MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR TWO SAMPLE IDS TESTED WITH THE KIT COBAS 6800/8800 WNV 480T IVD ASSAY ON THE COBAS 8800 SYSTEM. FOR SAMPLE ID (B)(6), THE FOLLOWING RESULTS WERE REPORTED: ON (B)(6)2023, THE SAMPLE TESTED REACTIVE ON INSTRUMENT 5091 WITH A TARGET 1 CYCLE THRESHOLD (CT) VALUE OF 39.23 AND AN INTERNAL CONTROL (IC) CT VALUE OF 36.75. ON (B)(6)2023, THE SAMPLE TESTED NON-REACTIVE ON INSTRUMENT 5158 WITH NO TARGET 1 CT VALUE AND AN IC CT VALUE OF 37.95. ON (B)(6)2023, THE SAMPLE TESTED NON-REACTIVE ON INSTRUMENT 5158 WITH NO TARGET 1 CT VALUE AND AN IC CT VALUE OF 37.05. ON (B)(6)2023, THE SAMPLE, RELABELED AS (B)(6), TESTED REACTIVE ON INSTRUMENT 5159 WITH A TARGET 1 CT VALUE OF 38.15 AND AN IC CT VALUE OF 36.93. FOR SAMPLE ID (B)(6), THE FOLLOWING RESULTS WERE REPORTED: ON (B)(6)2023, THE SAMPLE TESTED REACTIVE ON INSTRUMENT 5091 WITH A TARGET 1 CT VALUE OF 36.84 AND AN IC CT VALUE OF 36.38. ON (B)(6)2023, THE SAMPLE, POOLED INTO PP6_MPX_WNV ((B)(6), TESTED NON-REACTIVE ON INSTRUMENT 5158 WITH NO TARGET 1 CT VALUE AND AN IC CT VALUE OF 35.36. ON (B)(6)2023, THE SAMPLE TESTED NON-REACTIVE ON INSTRUMENT 5158 WITH NO TARGET 1 CT VALUE AND AN IC CT VALUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067545 ↗
• MalfunctionSep 16, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF FALSE POSITIVE COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS RESULTS FOR 1 PATIENT ON A COBAS® 6800 SYSTEM. THE INITIAL RESULT WAS POSITIVE. THE REPEATED RESULT WAS NORMAL, WITH A NEGATIVE RESULT. THE SAMPLE WAS REPEATED WITH A 1:2 DILUTION, AND THE RESULT WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062492 ↗