Elecsys Syphilis 09014977190Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613336171950), received between May 15, 2024 and May 11, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SYPHILIS ASSAY RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). SAMPLE 1: THE RESULT WAS 1.63 COI (REACTIVE). SAMPLE 2: THE RESULT WAS 1.37 COI (REACTIVE). IT WAS REPORTED THAT THE SAMPLE DILUTION DID NOT RESOLVE THE REACTIVITY, AND THE TEST RESULTS REMAINED REACTIVE. ADDITIONALLY, THE PATIENT SAMPLE WAS TESTED ON THE ABBOTT SYSTEM, WHERE A REACTIVE RESULT WAS OBTAINED. A CONFIRMATORY TEST WAS PERFORMED AND THE RESULT WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135305 ↗
• MalfunctionDec 22, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS SYPHILIS ON A COBAS 8000 E 602 MODULE. THE PATIENT SAMPLE RESULTED IN A SYPHILIS VALUE OF 3.42 COI (REACTIVE) AND IT REPEATED AS 3.70 COI (REACTIVE). THE SAMPLE WAS REPEATED AGAIN ON (B)(6) 2025, RESULTING IN A SYPHILIS VALUE OF 2.93 COI (REACTIVE). THE PATIENT WAS RE-TESTED IN OTHER LABORATORIES USING COMPETITOR SYSTEMS (ABBOTT ARCHITECT 2000I, ALINITY I SYPHILIS TP, AND CHAROITE ELISA ANALYZERS). ALL COMPETITOR SYSTEMS RETURNED NEGATIVE RESULTS. NO SPECIFIC RESULTS WERE PROVIDED. THE CUSTOMER NOTED THEY HAVE HAD PREVIOUS INCIDENTS OF THE SAME NATURE WHERE ELECSYS SYPHILIS RESULTS WERE POSITIVE AND COMPETITOR RESULTS WERE NEGATIVE. NO SPECIFIC INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23869994 ↗
• MalfunctionDec 5, 2025Output Problem; Output Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS SYPHILIS ASSAY ON A COBAS 6000 E601 MODULE. INITIAL RESULT: 11.74 COI. 1ST REPEAT RESULT: 11.26 COI (TESTED AFTER CENTRIFUGATION). THE SAMPLE WAS REPEATED ON A 3RD PARTY PLATFORM, RESULTING IN THE FOLLOWING: 2ND REPEAT RESULT: 0.276 (INTERPRETED AS NEGATIVE). 3RD REPEAT RESULT: 0.297 (INTERPRETED AS NEGATIVE). 4TH REPEAT RESULT: 0.252 (INTERPRETED AS NEGATIVE). THE SAMPLE WAS REPEATED USING A RAPID TEST STRIP, AND THE 5TH REPEAT RESULT WAS POSITIVE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730353 ↗
• MalfunctionNov 3, 2025Use of Incorrect Control/Treatment Settings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Device Handling Problem; Use of Incorrect Control/Treatment Settings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Device Handling Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE POSITIVE ELECSYS SYPHILIS RESULTS FROM THE COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 1.11 CUT-OFF INDEX COI (REACTIVE). THE FIRST REPEAT RESULT WAS 1.07 COI (REACTIVE). THE SECOND REPEAT RESULT WAS 1.26 COI (REACTIVE). THE "NON-TREPONEMAL RESULT" WAS NEGATIVE. THE ENZYME-LINKED IMMUNOSORBENT (ELISA) ASSAY RESULT WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23456679 ↗
• MalfunctionOct 15, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SYPHILIS RESULTS FROM THE COBAS E 602 MODULE FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT ON (B)(6) 2025 WAS 4.67 COI (REACTIVE). A SECOND SAMPLE WAS COLLECTED ON (B)(6) 2025 TO TEST FOR TREPONEMA PALLIDUM PARTICLE AGGLUTINATION (TPPA) AND TOLUIDINE RED UNHEATED SERUM TEST (TRUST), BOTH OF WHICH WERE NEGATIVE. A THIRD SAMPLE WAS COLLECTED ON (B)(6) 2025, AND THE INITIAL RESULT WAS 0.86 COI (NON-REACTIVE), AND THE REPEAT RESULT WAS 0.787 COI (NON-REACTIVE) PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 4.5 COI (REACTIVE). A SECOND SAMPLE WAS COLLECTED ON (B)(6) 2025 TO TEST FOR TREPONEMA PALLIDUM PARTICLE AGGLUTINATION (TPPA) AND TOLUIDINE RED UNHEATED SERUM TEST (TRUST), BOTH OF WHICH WERE NEGATIVE. THE SYPHILIS RESULT WAS 0.474 COI (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303384 ↗
• MalfunctionSep 17, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF A DISCREPANT RESULT WITH THE ELECSYS SYPHILIS FOR ONE PATIENT SAMPLE ON A COBAS E 602 MODULE. THE FOLLOWING RESULTS WERE PROVIDED: ELECSYS SYPHILIS RESULT: 0.097 COI, NON-REACTIVE. ENZYME-LINKED IMMUNOASSAY (ELISA) RESULT: 24.456 S/CO, REACTIVE. TREPONEMA PALLIDUM PARTICLE AGGLUTINATION (TPPA) TEST RESULT: REACTIVE. ELECTROCHEMILUMINESCENCE (ECLIA/CLIA) TEST RESULTS: NON-REACTIVE. WESTERN BLOT: NON-REACTIVE. NO ERRONEOUS RESULT WAS RELEASED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076153 ↗
• MalfunctionSep 16, 2025False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE-NEGATIVE ELECSYS SYPHILIS RESULTS FOR ONE PATIENT FROM THE COBAS 8000 CORE UNIT AND FOR ONE PATIENT FROM A COBAS 6000 E601 MODULE. 2. PATIENT AGE RANGE: 35 YEAR 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: 1-MALE, 1-ASKU 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066025 ↗
• MalfunctionAug 20, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE NEGATIVE ELECSYS SYPHILIS RESULT FROM THE COBAS E 411 ANALYZER (RACK SYSTEM). PREVIOUSLY, TREPONEMA PALLIDUM PASSIVE HEMAGGLUTINATION (TPHA) AND RAPID PLASMA REAGIN (RPR) WERE PERFORMED, WITH BOTH TESTS BEING POSITIVE, AND THE PATIENT'S CLINICAL INDICATION WAS THAT HE HAD SYPHILIS. WHEN THE SAMPLE WAS ANALYZED ON THE E 411, THE RESULT WAS NON-REACTIVE (NEGATIVE). IT IS NOT KNOWN WHEN THE SAMPLE WAS TESTED OR IF IT WAS PROCESSED FROM THE SAME TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850666 ↗
• MalfunctionJun 5, 2025False Negative Result; False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR A PATIENT¿S SAMPLE TESTED WITH ELECSYS SYPHILIS ON A COBAS 8000 CORE UNIT. THE SAMPLE WAS INITIALLY TESTED AND REPEATED ON A COBAS E602 ANALYZER, AND THE RESULTS WERE 0.344 COI AND 0.346 COI (BOTH RESULTS WERE INTERPRETED AS NON-REACTIVE). THE SAMPLE WAS THEN REPEATED ON A COBAS E801 ANALYZER, AND THE 2ND REPEAT RESULT WAS 0.454 COI (THIS RESULT WAS INTERPRETED AS NON-REACTIVE). THE NON-REACTIVE ELECSYS SYPHILIS RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, AND THE SAMPLE WAS REPEATED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. 3RD REPEAT RESULT: 3.41 S/CO (INTERPRETED AS REACTIVE WHEN TESTED WITH WAN200). 4TH REPEAT RESULT: INTERPRETED AS REACTIVE WHEN TESTED WITH TREPONEMA PALLIDUM PARTICLE AGGLUTINATION (TPPA) TEST. 5TH REPEAT RESULT: INTERPRETED AS REACTIVE WHEN TESTED WITH TOLUIDINE RED UNHEATED SERUM TEST (TRUST) WITH A DILUTION FACTOR OF 1:2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148855 ↗
• MalfunctionMay 27, 2025False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED A NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS SYPHILIS (SYPHILIS) ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 0.057 COI (NEGATIVE). THIS RESULT WAS NOT CONSISTENT WITH THE PATIENT¿S HISTORICAL RESULTS, AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 6.77 COI (POSITIVE). THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087047 ↗
• MalfunctionJan 30, 2025False Negative Result; Incorrect Measurement; False Negative Result; Incorrect Measurement

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS SYPHILIS ASSAY RESULTS FROM THREE SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS 6000 CORE UNIT. SAMPLE 1 ON (B)(6)2024: THE RESULT FROM THE ANALYZER WAS 0.092 (NEGATIVE). THE RESULT FROM THE ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) ASSAY WAS 12.515. SAMPLE 2 ON (B)(6) 2025: THE RESULT FROM THE ANALYZER WAS 0.077 (NEGATIVE). THE RESULT FROM THE ELISA ASSAY WAS 10.189. SAMPLE 3 ON (B)(6) 2025: THE RESULT FROM THE ELISA ASSAY WAS 11.619. THE RESULT FROM THE ANALYZER WAS NEGATIVE. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275257 ↗
• MalfunctionSep 12, 2024False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT A QUESTIONABLE NEGATIVE RESULT FOR 1 PATIENT SERUM SAMPLE TESTED WITH ELECSYS SYPHILIS ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM). INITIAL RESULT: NEGATIVE (0.15 COI). THE BABY WAS TESTED AND THE RESULT WAS POSITIVE WHICH PROMPTED A NEW SAMPLE TO BE DRAWN AND TESTED FROM THE PATIENT (MOM). THE RESULT OF THE NEW SAMPLE WAS POSITIVE. ON (B)(6) 2024, THE ORIGINAL SAMPLE WAS THEN REPEATED AND THE REPEAT RESULT WAS POSITIVE. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20203466 ↗
• MalfunctionMay 15, 2024False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT A FALSE NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS SYPHILIS ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER. INITIAL RESULT: 1.23 COI (TESTED USING SERUM AND INTERPRETED AS REACTIVE). 1ST REPEAT RESULT: 1.15 COI (TESTED USING SERUM AND INTERPRETED AS REACTIVE). 2ND REPEAT RESULT: 0.935 COI (TESTED USING PLASMA FROM THE BLOOD BAG AND INTERPRETED AS NON-REACTIVE). ON (B)(6) 2024 THE SAMPLE WAS REPEATED ON A DIFFERENT COBAS E411 IMMUNOASSAY ANALYZER IN ANOTHER FACILITY AND OBTAINED THE FOLLOWING RESULTS: 3RD REPEAT RESULT: 1.53 COI (TESTED USING SERUM AND INTERPRETED AS REACTIVE). 4TH REPEAT RESULT: 1.58 COI (TESTED USING SERUM AND INTERPRETED AS REACTIVE). 5TH REPEAT RESULT: 1.54 COI (TESTED USING SERUM AND INTERPRETED AS REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322118 ↗