Elecsys Syphilis 06923348190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04015630934881), received between Apr 25, 2019 and Sep 16, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025False Positive Result; False Positive Result

  1. THERE WAS AN ALLEGATION OF FALSE-POSITIVE ELECSYS SYPHILIS RESULTS: 5 PATIENT- COBAS 6000 E601 MODULE. 2 PATIENT- COBAS 8000 - COBAS E 602 MODULE. 6 PATIENT- COBAS E 801 ANALYTICAL UNIT. 1 PATIENT- COBAS E 801 MODULE. 1 PATIENT- UNKNOWN ANALYZER 2. PATIENT AGE RANGE: 7 -55 YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 3-FEMALE, 5-MALE, 8-ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066029 ↗
• MalfunctionSep 16, 2025False Negative Result; False Negative Result

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR ELECSYS SYPHILIS: 1 PATIENT-COBAS 8000 E 602 MODULE AND A COBAS E 411 ANALYZER. 2 PATIENT -COBAS 8000 E 801 MODULE. 3 PATIENT-COBAS E 801 ANALYTICAL UNIT. 3 PATIENT-COBAS 8000 CORE UNIT. 2 PATIENT-COBAS 8000 - COBAS E 602 MODULE. 1 PATIENT-COBAS 6000 CORE UNIT. 2. PATIENT AGE RANGE: 18 MONTH-75 YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 2-FEMALE. 4-MALE. 6-ASKU. 5. PATIENT RACE BREAKDOWN: 1-ASIAN. 11-ASKU. 6. PATIENT ETHNICITY BREAKDOWN: 1-NON-HISPANIC/LATINO. 11-ASKU.

  Patient problems: Insufficient Information; Localized Skin Lesion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065297 ↗
• MalfunctionSep 26, 2024False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SYPHILIS RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 E 602 MODULE. THE ELECSYS SYPHILIS RESULT WAS 0.863 COI (NEGATIVE). THE RESULTS USING OTHER METHODS WERE: POSITIVE WITH THE TPPA METHOD, POSITIVE (4.69 UNIT OF MEASURE WAS NOT PROVIDED) WITH THE WAN200 (TREPONEMAL, CHEMICAL LUMINESCENCE TEST) METHOD, POSITIVE WITH THE IMMUNOGOLD (TREPONEMAL) METHOD, AND NEGATIVE WITH THE TRUST METHOD. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED DUE TO THE RESULT NOT MATCHING THE PATIENT'S CLINICAL DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20316093 ↗
• MalfunctionJun 13, 2024False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THEY RECEIVED A FALSE NEGATIVE RESULT FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS SYPHILIS ON A COBAS 6000 E601 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE VALUES MEASURED WITH THE ELECSYS SYPHILIS ASSAY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE PATIENT SAMPLE RESULTED IN A SYPHILIS VALUE OF 0.133 COI (NON-REACTIVE). THE SAMPLE WAS REPEATED AND THE RESULT WAS STILL NEGATIVE. ELISA TESTING PERFORMED ON THE PATIENT SAMPLE RESULTED IN A VALUE OF 18.67 (REACTIVE WITH CUTOFF OF 0.14). NO UNITS OF MEASURE WERE PROVIDED FOR THE METHOD. IMMUNOCHROMATOGRAPHY TEST STRIPS, TPPA, AND RPR TESTING PERFORMED ON THE PATIENT WERE ALL POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527817 ↗
• MalfunctionSep 1, 2022False Negative Result; False Negative Result

  THE INITIAL REPORTER QUESTIONED NEGATIVE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS SYPHILIS (SYPHILIS) ON A COBAS 6000 E 601 MODULE. ON (B)(6) 2021: THE RESULT FROM THE E601 MODULE WAS 0.580 COI (NEGATIVE). THE RESULT FROM THE INTECH TREPONEMA PALLIDUM PARTICLE AGGLUTINATION (TPPA) METHOD WAS "POSITIVE." THE ACTUAL RESULT WAS NOT PROVIDED. ON (B)(6) 2022: THE RESULT FROM THE E601 MODULE WAS 0.790 COI (NEGATIVE). THE RESULT FROM THE INTECH TPPA METHOD WAS "POSITIVE." THE ACTUAL RESULT WAS NOT PROVIDED. ADDITIONAL SYPHILIS RESULTS WERE PROVIDED FROM 2 OTHER METHODS: THE RESULT FROM THE FUJIREBIO TPPA METHOD WAS "POSITIVE." THE ACTUAL RESULT WAS NOT PROVIDED. THE RESULT FROM THE TRUST METHOD WAS "NEGATIVE." THE ACTUAL RESULT WAS NOT PROVIDED. IT IS NOT CLEAR IF THE RESULTS FROM THE ADDITIONAL METHODS WERE FROM ONE OF THE SAMPLES FROM 2021 OR 2022 OR A DIFFERENT SAMPLE. CLARIFICATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. THE QUESTIONABLE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E601 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15333824 ↗
• MalfunctionJul 30, 2021False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS SYPHILIS RESULTS FOR ONE PATIENT TESTED ON TWO COBAS 8000 E 602 MODULES. THE PATIENT HAD TWO SAMPLES COLLECTED FOR TESTING. ON 16-JUN-2021, THE CUSTOMER PERFORMED SYPHILIS ANTIBODY TESTING ON AN ABBOTT ALINITY ANALYZER AND A MANUAL RPR SYPHILIS ANTIGEN TEST WITH THE PATIENT'S FIRST SAMPLE. FOR CONFIRMATION, THE CUSTOMER HAD A SECOND SAMPLE COLLECTED ON (B)(6) 2021. BOTH SAMPLES WERE TESTED ON THE E 602 MODULES AS WELL AS THE ABBOTT ALINITY ANALYZER. THE CUSTOMER PROVIDED A SERIAL NUMBER FOR ONE E 602 MODULE, (B)(4) , THE OTHER E 602 MODULE SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER DID NOT SPECIFY E 602 MODULE THE PROVIDED SERIAL NUMBER BELONGED TO. THE PATIENT'S ABBOTT SYPHILIS REACTIVE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S ELECSYS SYPHILIS NON-REACTIVE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253270 ↗
• MalfunctionApr 25, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. LOW RESULTS WERE GENERATED BY THE COBAS 8000 E 602 MODULE FOR ELECSYS SYPHILIS. THE EVENT INVOLVED A TOTAL OF 1 PATIENT. THERE PATIENT IS MALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549725 ↗