cobas® HIV-1/HIV-2 Qualitative 09040528190Recalls & reported problems
Roche Molecular Systems, Inc. · Class 2
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 00875197006384), received between Sep 18, 2025 and Aug 12, 2026 — 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
- False Negative Result1
- Output Problem1
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.
MalfunctionAug 12, 2026False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50219809 ↗MalfunctionJun 3, 2026False Positive Result
THERE WAS AN ALLEGATION OF DISCREPANT COBAS® HIV-1/HIV-2 QUALITATIVE (192T) RESULTS FROM THE COBAS 5800 ANALYZER FOR A SINGLE PATIENT. ON (B)(6) 2026, THE INITIAL SAMPLE WAS GENERATED HIV-1 REACTIVE (38.9), HIV-2 NON-REACTIVE RESULTS. REPEAT ON (B)(6) 2026 GENERATED HIV-1 REACTIVE (38.21), HIV-2 NON-REACTIVE RESULTS. THE ELECSYS HIV COMBI GENERATED A POSITIVE RESULT (3,63 - 3,68 ¿ 3,73 S/CO). THE BIO-RAD GEENIUS HIV 1/2 SUPPLEMENTAL ASSAY GENERATED A NEGATIVE RESULT. SEROLOGY WAS NEGATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25373029 ↗MalfunctionSep 18, 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 FIVE DISCREPANT RESULTS WHEN TESTING WITH THE KIT C58/68/88 HIV-1/HIV-2 QUAL 192T IVD ASSAY ON THE COBAS 8800 SYSTEM. THREE OF THE SAMPLES WERE PLASMA PREPARATION TUBES (PPT), AND TWO WERE PLASMA SAMPLES. ONE OF THE FIVE DISCREPANT RESULTS INVOLVED A KNOWN HIGH-TITER HIV PATIENT SAMPLE TESTED AS PART OF A VALIDATION PROCESS, WHICH YIELDED A NEGATIVE RESULT. THE SAME SAMPLE WAS ALSO TESTED ON A HOLOGIC PLATFORM; HOWEVER, THE RESULTS OF THIS TEST ARE NOT KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085584 ↗
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- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2648Alere Scarborough, Inc. · Test, Hiv Detection238 reports
- Elecsys HIV Duo 08836973190Roche Diagnostics GmbH · Test, HIV detection105 reports
- ARCHITECT 2P36-01Abbott GmbH · Test, hiv detection1 recall0 reports
- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2649Alere Scarborough, Inc. · Test, Hiv Detection27 reports
- cobas® HIV-1 09040803190Roche Molecular Systems, Inc. · Test, HIV detection27 reports
- VITROS 6842781Ortho Clinical Diagnostics · Test, hiv detection16 reports
- RealTime 6L18-90Abbott Molecular Inc. · Test, hiv detection12 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
- 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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