Elecsys HTLV-I/II 09015272162Recalls & reported problems
Roche Diagnostics GmbH · Class U
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 07613336183090), received between Dec 23, 2025 and May 29, 2026 — 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
- False Positive Result1
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.
MalfunctionMay 29, 2026False Positive Result
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HTLV-I/II AND ELECSYS SYPHILIS RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE ELECSYS HTLV-I/II RESULT WAS REACTIVE. ON (B)(6) 2026, THE (WESTERN BLOT METHOD) CONFIRMATORY HTLV TEST RESULT WAS "CONFIRMED INDETERMINATE". THE ELECSYS SYPHILIS RESULT WAS REACTIVE ON (B)(6) 2026, THE (CAPTIA-G METHOD) CONFIRMATORY SYPHILIS TEST RESULT WAS "CONFIRMED NON-REACTIVE". THE SAMPLE WAS REPEATED BECAUSE OF THE INITIALLY REACTIVE RESULTS. THIS MEDWATCH WILL APPLY TO THE ELECSYS HTLV-I/II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS SYPHILIS ASSAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333412 ↗MalfunctionDec 23, 2025False Negative Result; False Negative Result
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HTLV-I/II RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT WHILE PERFORMING VALIDATION TESTING. THE INITIAL RESULT WAS REPEATEDLY POSITIVE USING AN ABBOT ALINITY SYSTEM. THE REPEAT RESULT FROM THE COBAS E801 WAS 0.112 COI (NON-REACTIVE). NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. IT WAS UNKNOWN WHICH RESULT WAS CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23876448 ↗
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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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