Elecsys SyphilisRecalls & reported problems across all models

We found 5 models of Elecsys Syphilis by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Apr 25, 2019 and Jun 4, 2026 — classified as 4 injuries, 53 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (34 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys Syphilis problems

Elecsys Syphilis models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys Syphilis 09015051190

  ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
  28 reports
• Elecsys Syphilis 09014977190

  ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
  13 reports
• Elecsys Syphilis 06923348190

  ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
  7 reports
• Elecsys Syphilis 07251378190

  ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
  7 reports
• Elecsys Syphilis 09015051162

  Test, donor, syphilis, antigens, treponemal
  2 reports

Recent Elecsys Syphilis adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT TESTED WITH ELECSYS SYPHILIS ON MULTIPLE ANALYZERS. THE SAMPLES WERE COLLECTED FROM A CLINICIAN WHO EXPERIENCED A NEEDLESTICK INJURY FROM A PATIENT WITH ACTIVE SYPHILIS. THE FIRST SAMPLE WAS TESTED ON THE CUSTOMER'S E 801 ANALYZER, RESULTING IN SYPHILIS VALUES OF 17.1 COI (REACTIVE) AND 17.2 COI (REACTIVE). THE SAMPLE WAS REPEATED USING THE ABBOTT METHOD, RESULTING IN A VALUE OF 0.35 S/CO. THE SAMPLE WAS RE-CENTRIFUGED IN A HIGH-SPEED CENTRIFUGE AND TESTED ON A SECOND UNKNOWN ROCHE ANALYZER, RESULTING IN A SYPHILIS VALUE OF 17.0 COI (REACTIVE). A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND IT RESULTED IN A SYPHILIS VALUE OF 16.9 COI WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLE WAS REPEATED ON A COBAS E 411 ANALYZER, RESULTING IN A SYPHILIS VALUE OF 15.86 COI (REACTIVE). BOTH SAMPLES WERE SENT TO DIFFERENT LABORATORIES FOR RPR AND TPPA TESTING AND ALL RESULTS CAME BACK AS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394661 ↗
• MalfunctionJun 2, 2026False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE REACTIVE ELECSYS SYPHILIS RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR 1 PATIENT. THE INITIAL RESULT WAS 1.2 COI (REACTIVE). THE SAMPLE WAS RETESTED USING THE AUTOBIO PLATFORM AND TREPONEMA PALLIDUM PARTICLE AGGLUTINATION (TPPA), AND BOTH RESULTS WERE NEGATIVE. THE RESULT OF 1.2 COI WAS REPORTED, AND THE DOCTOR ORDERED A REPEAT BLOOD DRAW OUT OF CAUTION OF TREATING THE PATIENT WITH PENICILLIN. ON (B)(6) 2026, WITH A NEW SAMPLE, THE RESULT WAS 0.4 COI (NON-REACTIVE). TO INVESTIGATE THE DISCREPANCY, THE CUSTOMER RE-CENTRIFUGED THE REFRIGERATED SAMPLE #1 AND RE-TESTED IT; THE RESULT WAS 9.88 COI (REACTIVE). ON (B)(6) 2026, BOTH SAMPLES WERE RE-CENTRIFUGED AND RE-TESTED: SAMPLE #1'S RESULT WAS 10.0 COI (REACTIVE), AND SAMPLE #2'S RESULT WAS 1.4 COI (REACTIVE). ON (B)(6) 2026, THE CENTRIFUGED SERUM FROM BOTH SAMPLES WAS CROSS-TESTED ON THE ABBOTT PLATFORM, AND BOTH YIELDED NEGATIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359679 ↗
• 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 ↗
• MalfunctionMay 18, 2026False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SYPHILIS RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO TWO COMPETITOR ASSAYS. THE PATIENT HAD AN ELECSYS SYPHILIS RESULT OF 0.259 COI (NON-REACTIVE), AN ABBOTT SYPHILIS RESULT OF 0.53 S/CO (NON-REACTIVE), AND AN AUTOBIO SYPHILIS RESULT OF 9.984 (REACTIVE). THE UNITS OF MEASUREMENT FOR THE AUTOBIO RESULT WERE NOT PROVIDED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204420 ↗
• 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 ↗
• MalfunctionApr 20, 2026False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED INCONSISTENT RESULTS FOR SAMPLES COLLECTED FROM ONE PATIENT TESTED WITH ELECSYS SYPHILIS ON A COBAS E 801 ANALYTICAL UNIT. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. TUBES 1001, 1002, AND 1003 WERE COLLECTED AT THE SAME TIME. TUBE 1001 IS A HEPARIN PLASMA TUBE. TUBE 1002 IS AN EDTA PLASMA TUBE. TUBES 1003-1006 ARE SERUM TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924182 ↗
• MalfunctionApr 6, 2026False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SYPHILIS RESULTS FROM THE COBAS PRO SSU ANALYZER (COBAS E801). THE INITIAL RESULT WAS 0.75 COI (NON-REACTIVE), AND THE REPEAT RESULT WAS 0.76 COI (NON-REACTIVE). THE SAMPLE WAS TESTED FOR CONFIRMATION, AND THE TRUST AND TPPA RESULT WAS 8 COI (REACTIVE) USING THE WANTAI ASSAY. A SUBSEQUENT 1:3 DILUTION ON THE COBAS E801 PRODUCED A RESULT OF 0.313 COI (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788708 ↗
• MalfunctionApr 3, 2026False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS SYPHILIS ON A COBAS E 801 ANALYTICAL UNIT. THE PATIENT SAMPLE RESULTED IN SYPHILIS VALUES OF 5.26 COI (REACTIVE), 5.28 COI (REACTIVE), AND 5.27 COI (REACTIVE). THE PATIENT RECEIVED AN RPR TEST AND THIS WAS FOUND TO BE NON-REACTIVE. THE COMPLAINED PATIENT SAMPLE WAS TESTED WITH A FLUORESCENT TREPONEMAL ANTIBODY TEST AT AN OUTSIDE LABORATORY AND THE RESULT WAS NON-REACTIVE. BASED ON THE PATIENT'S CLINICAL PRESENTATION, THEY DID NOT RECEIVE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777710 ↗
• MalfunctionMar 5, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV DUO AND ELECSYS SYPHILIS RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER SYPHILIS. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6). FOR INFORMATION ON THE HIV DUO RESULTS. THE HIV DUO RESULT WAS 1.61 COI, WITH THE HIV ANTIGEN RESULT BEING 1.61 COI AND THE ANTI-HIV RESULT BEING 0.093 COI, AND THE SYPHILIS RESULT WAS 2.41 COI. BOTH RESULTS WERE INTERPRETED AS REACTIVE. THE SAMPLE WAS RE-CENTRIFUGED AND THE RESULTS WERE CONSISTENT AFTER RETESTING. THE REPEAT RESULTS WERE NOT PROVIDED. THE PATIENT HAS NO HISTORY HIV OR SYPHILIS INFECTIONS AND PREVIOUSLY HAD NON-REACTIVE RESULTS AT ANOTHER HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520829 ↗
• InjuryFeb 25, 2026False Negative Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE FALSE-NEGATIVE ELECSYS SYPHILIS RESULT FROM THE COBAS E 801 MODULE. ONE DONOR PROVIDED TWO BLOOD DONATIONS IN 2025: FOR THE FIRST DONATION IN (B)(6) 2025, THE RESULT WAS REPORTED TO BE 0.116 COI (NON-REACTIVE). BASED ON THIS RESULT, THE DONATION WAS ALLEGEDLY RELEASED FOR FURTHER UTILIZATION AS THE BASIS FOR FURTHER BLOOD PRODUCT PRODUCTION. FOR THE SECOND DONATION IN (B)(6) 2025, THE RESULT WAS REPORTED TO BE 292 COI (REACTIVE). AS PART OF A "LOOK-BACK PROCEDURE", THE DONATION FROM (B)(6) WAS RETESTED USING ABBOTT METHODOLOGY, AND THE RESULT WAS REPORTED TO BE 6.54 S/CO (REACTIVE). FURTHER TESTING (IGG) INDICATED THAT THE SAMPLE WAS DRAWN AFTER INFECTION. INFORMATION WAS REQUESTED, BUT NOT YET RECEIVED IF THE DONATION FROM (B)(6) 2025 WAS ACTUALLY UTILIZED OR TRANSFUSED. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: Insufficient Information

  MAUDE report 24444004 ↗
• MalfunctionFeb 2, 2026False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH ELECSYS SYPHILIS ON A COBAS 8000 E 801 MODULE. THE FIRST SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A SYPHILIS VALUE OF 32.6 COI (REACTIVE). AFTER RE-CENTRIFUGATION, THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 31.0 COI (REACTIVE). TPPA AND TRUST RESULTS FROM THIS SAMPLE WERE NEGATIVE. THE SAMPLE WAS TREATED WITH A HETEROPHILIC ANTIBODY BLOCKING TUBE AND REPEATED TWICE ON (B)(6) 2026, RESULTING IN SYPHILIS VALUES OF 30.8 COI (REACTIVE) AND 31.1 COI (REACTIVE). A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A SYPHILIS VALUE OF 31.0 COI (REACTIVE) ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234333 ↗
• MalfunctionJan 30, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SYPHILIS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 9.8 COI (POSITIVE). THE REPEAT RESULT WAS 9.96 COI (POSITIVE). THE SAME SAMPLE WAS TESTED ON ANOTHER COBAS E801 PLATFORM, AND THE RESULT WAS POSITIVE (NO SPECIFIC RESULT WAS PROVIDED). THE SAMPLE WAS TESTED USING OTHER METHODS: ANTU A2000PLUS SYPHILIS: 0.422 COI (NEGATIVE). ANTU A2000PLUS SYPHILIS: 0.436 COI (NEGATIVE). IFLASH 3000H SYPHILIS: 0.05 COI (NEGATIVE). TPPA (NEGATIVE). TRUST (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223465 ↗
• MalfunctionJan 15, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SYPHILIS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.78 COI (REACTIVE). THE RESULT AFTER HIGH-SPEED CENTRIFUGATION WAS 1.78 COI (REACTIVE). A NEW BLOOD SAMPLE WAS TAKEN AND TESTED ON ANOTHER 801 PLATFORM, WITH A RESULT OF 1.93 COI (REACTIVE). THE RESULT AFTER HIGH-SPEED CENTRIFUGATION WAS 1.98 COI (REACTIVE). THE TPPA RESULT WAS NEGATIVE. WHEN THE SAMPLE WAS TESTED ON THE ABBOTT PLATFORM, THE RESULT WAS 0.08 (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077915 ↗
• 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 ↗

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