Elecsys HIV combi PT 08924180160Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336170212), received between Aug 15, 2025 and Nov 18, 2025 — classified as 2 malfunctions.
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. 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 Negative Result1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025False Negative Result; False Negative Result
THE CUSTOMER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HIV COMBI PT ON A COBAS 8000 E 602 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN HIV COMBI PT VALUE OF 0.2 COI (NON-REACTIVE). THE SAMPLE WAS TESTED ON AN ABBOTT POINT OF CARE TEST STRIP FOR HIV 1/2 AG/AB COMBO AND FREE HIV-1 P24; IT WAS POSITIVE FOR THE P24 ANTIGEN. THE SAMPLE WAS REPEATED ON THE E 602 ANALYZER AND THE HIV COMBI PT VALUE WAS NEGATIVE. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR CONFIRMATORY TESTING AND THE RESULTS FOR HIV-1 AND HIV-2 WERE BOTH NEGATIVE. HIV 1 AND HIV 2 RNA WERE UNDETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23585685 ↗MalfunctionAug 15, 2025Non Reproducible Results; Non Reproducible Results
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV COMBI PT RESULTS FROM THE COBAS E 602 MODULE. THE INITIAL RESULT WAS 1.4 COI (REACTIVE). THE SAMPLE WAS REPEATED TWICE, WITH A RESULT OF >5000 COI (REACTIVE) EACH TIME. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AT THE SITE, AND THE RESULT WAS >1.0 COI (REACTIVE). NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816285 ↗
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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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