Elecsys Syphilis 09015051162Recalls & reported problems
Roche Diagnostics GmbH · Class 2
All models of Elecsys Syphilis (5)
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 07613336183083), received between Nov 26, 2025 and May 29, 2026 — classified as 2 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
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 AND QUESTIONABLE ELECSYS SYPHILIS RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE ELECSYS SYPHILIS RESULT WAS REACTIVE ON (B)(6) 2026, THE (CAPTIA-G METHOD) CONFIRMATORY SYPHILIS TEST RESULT WAS "CONFIRMED NON-REACTIVE". THE ELECSYS HTLV-I/II RESULT WAS REACTIVE. ON (B)(6) 2026, THE (WESTERN BLOT METHOD) CONFIRMATORY HTLV TEST RESULT WAS "CONFIRMED INDETERMINATE". PATIENT 2: ON (B)(6) 2026, THE ELECSYS SYPHILIS RESULT WAS REACTIVE THE (CAPTIA-G METHOD) CONFIRMATORY SYPHILIS TEST RESULT WAS "CONFIRMED NON-REACTIVE". THE SAMPLES WERE REPEATED BECAUSE OF THE INITIALLY REACTIVE RESULTS. THIS MEDWATCH WILL APPLY TO THE ELECSYS SYPHILIS ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS HTLV-I/II ASSAY RESULTS FOR PATIENT 1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333407 ↗MalfunctionNov 26, 2025False Positive Result; False Positive Result
THERE WAS AN ALLEGATION OF A QUESTIONABLE REACTIVE ELECSYS SYPHILIS RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 8.18 COI (REACTIVE). THE FIRST REPEAT RESULT WAS 8.20 COI (REACTIVE). THE SECOND REPEAT RESULT WAS 8.17 COI (REACTIVE). THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING USING THE CAPTIA SYPHILIS G APPLICATION, AND THE RESULT WAS NON-REACTIVE. THE NON-REACTIVE RESULT WAS DEEMED TO BE CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23657150 ↗
Other Test, donor, syphilis, antigens, treponemal devices
- TPHA Screen 0066826Immucor, Inc. · Test,Donor,Syphilis,Antigens,Treponemal3 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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