Elecsys Syphilis 09015051190Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07613336171998), received between Feb 21, 2022 and Jun 4, 2026 — classified as 4 injuries, 24 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (15 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 25 most recent of 28 reports, 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 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 ↗
• 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 4, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR SAMPLES FROM SIX PATIENTS TESTED WITH ELECSYS SYPHILIS ON COBAS E 801 ANALYTICAL UNIT ANALYZERS. PLEASE REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. SAMPLES FROM PATIENTS 1 AND 2 WERE TESTED ON E 801 ANALYZER SERIAL NUMBER (B)(6). SAMPLES FROM PATIENTS 3-6 WERE TESTED ON TWO DIFFERENT E 801 ANALYZERS. FOR PATIENTS 4-6, THE RESULTS FROM THE SERUM TUBES WERE IN LINE WITH CLINICAL FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719557 ↗
• MalfunctionNov 25, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SYPHILIS RESULTS FROM THE COBAS E 801 MODULE. THE CUSTOMER TESTED SAMPLES USING TWO COBAS E 801 MODULES AND TWO DIFFERENT LOTS OF REAGENT, WITH ALL SAMPLES RESULTING AS REACTIVE/DETECTED. THE RESULTS FOR THE SAME SAMPLES USING DIASORIN LIAISON XL WERE ALL NON-REACTIVE/NOT DETECTED. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647684 ↗
• MalfunctionNov 20, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH MULTIPLE ASSAYS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED ON A COBAS E 801 ANALYTICAL UNIT. ELECSYS HBSAG II: 438 COI ELECSYS HBSAG II QUANT II: 12.40 IU/ML (DETECTABLE) ELECSYS SYPHILIS: 12.6 COI ELECSYS HIV DUO: 96.3 COI HIV IMMUNOBLOTTING RESULT: NEGATIVE SYPHILIS CONFIRMATION (VDRL AND TPHA): NEGATIVE THE PATIENT¿S GENERAL PRACTITIONER REQUESTED A REPEAT RUN. ON (B)(6) 2025, A NEW SAMPLE WAS RUN, AND THE RESULTS WERE NEARLY IDENTICAL TO THE INITIAL TEST. THE SCREENING TESTS SHOWED HIGH COI VALUES, WHILE ALL CONFIRMATORY TESTS AND PCR RESULTS WERE NEGATIVE. THIS MEDWATCH WILL COVER ELECSYS SYPHILIS. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ELECSYS HBSAG II RESULTS, AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ELECSYS HIV DUO RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606847 ↗
• MalfunctionOct 20, 2025False Negative Result; False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS SYPHILIS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 1.21 COI (INTERPRETED AS POSITIVE AND TESTED ON VITROS ORTHO USING CHEMILUMINESCENT IMMUNOASSAY CLIA LABORATORY METHOD). 1ST REPEAT RESULT: POSITIVE (TESTED WITH WESTERN BLOT). 2ND REPEAT RESULT: 0.731 COI (INTERPRETED AS NEGATIVE AND TESTED ON COBAS E 801). 3RD REPEAT RESULT: POSITIVE (TESTED ON VITROS AFTER BEING FROZEN AND THAWED). SAMPLE 2: INITIAL RESULT: 4.8 COI (INTERPRETED AS POSITIVE AND TESTED ON VITROS ORTHO - CLIA LABORATORY METHOD). 1ST REPEAT RESULT: POSITIVE (TESTED WITH WESTERN BLOT). 2ND REPEAT RESULT: 0.979 COI (INTERPRETED AS NEGATIVE AND TESTED ON COBAS E 801). 3RD REPEAT RESULT: POSITIVE (TESTED ON VITROS AFTER BEING FROZEN AND THAWED). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335820 ↗
• MalfunctionOct 15, 2025False Negative Result; False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS TESTED WITH ELECSYS SYPHILIS ASSAY ON COBAS E 801 MODULE ANALYZERS. THE CUSTOMER ALLEGEDLY STARTED INTERNALLY APPLYING THEIR OWN GREY ZONE FOR THE ELECSYS SYPHILIS ASSAY OF 0.5 - 1.0 COI. SAMPLES WITH RESULTS IN THIS RANGE ARE THEN REPORTEDLY RE-ANALYZED USING THE ABBOTT ARCHITECT METHOD. THE CUSTOMER ALLEGED THAT APPROXIMATELY 15 PATIENT SAMPLES PER DAY FALL WITHIN THIS GREY ZONE RANGE. TWO SAMPLES (SAMPLE 1 AND SAMPLE 2) WERE DRAWN FROM PATIENT 1 AND TESTED ON E 801 ANALYZER SERIAL NUMBER (B)(6). SAMPLE 1 WAS TESTED AND REPORTEDLY RESULTED IN THE FOLLOWING: INITIAL RESULT: 0.849 COI (TESTED WITH ELECSYS SYPHILIS AND INTERPRETED AS NON-REACTIVE). 1ST REPEAT RESULT: 1.02 S/CO (TESTED WITH ABBOTT AND INTERPRETED AS REACTIVE). 2ND REPEAT RESULT: NEGATIVE (TESTED WITH RAPID PLASMA REAGIN (RPR) METHOD). 3RD REPEAT RESULT: NEGATIVE (TESTED WITH IMMUNO BLOT METHOD). SAMPLE 2 WAS TESTED ON (B)(6) 2025 AND REPORTEDLY RESULTED IN THE FOLLOWING: INITIAL RESULT: 169 COI (TESTED WITH ELECSYS SYPHILIS AND INTERPRETED AS REACTIVE). 1ST REPEAT RESULT: 170 COI (TESTED WITH ELECSYS SYPHILIS AND INTERPRETED AS REACTIVE). 2ND REPEAT RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303636 ↗
• MalfunctionSep 16, 2025Incorrect Measurement; Incorrect Measurement

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 30 PATIENTS TESTED WITH ELECSYS SYPHILIS ON A COBAS E 801 MODULE AND A COBAS 6000 E 601 MODULE. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066002 ↗
• InjurySep 9, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER ALLEGED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS SYPHILIS ON COBAS E 801 MODULE ANALYZERS. THE CUSTOMER ALLEGEDLY STARTED INTERNALLY APPLYING THEIR OWN GREY ZONE FOR THE ELECSYS SYPHILIS ASSAY OF 0.5 - 1.0 COI. SAMPLES WITH RESULTS IN THIS RANGE ARE THEN REPORTEDLY RE-ANALYZED USING THE ABBOTT ARCHITECT METHOD. THE CUSTOMER ALLEGES THAT APPROXIMATELY 15 PATIENT SAMPLES PER DAY FALL WITHIN THIS GREY ZONE RANGE. THE FIRST PATIENT'S SAMPLE REPORTEDLY RESULTED IN A SYPHILIS VALUE OF 0.736 COI (NON-REACTIVE) WHEN TESTED ON E 801 ANALYZER SERIAL NUMBER (B)(6). THE SAMPLE WAS REPEATED WITH THE ABBOTT ASSAY ON (B)(6) 2025, REPORTEDLY EACH TIME RESULTING IN A VALUE OF 5.08 S/CO (REACTIVE). IT WAS REPORTED THAT THE CUSTOMER DID NOT YET APPLY THE NEW GREY ZONE RANGE WHEN THE SAMPLE WAS INITIALLY TESTED, SO THE BLOOD COMPONENTS OF THIS DONATION WERE NOT BLOCKED. THE SECOND PATIENT'S SAMPLE REPORTEDLY RESULTED IN A SYPHILIS VALUE OF 0.537 COI (NON-REACTIVE) WHEN TESTED ON E 801 ANALYZER SERIAL NUMBER (B)(6) ON (B)(6) 2025. THIS SAMPLE WAS REPEATED WITH THE ABBOTT ASSAY, REPORTEDLY RESULTING IN A VALUE OF 4.43 S/CO (REACTIVE) ON (B)(6) 202

  Patient problems: Insufficient Information

  MAUDE report 23008843 ↗
• InjuryAug 4, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE FALSE NEGATIVE ELECSYS SYPHILIS RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYZER. BASED ON A RETROSPECTIVE DATA ANALYSIS, A DONOR SAMPLE THAT HAD PREVIOUSLY CONSISTENTLY TESTED POSITIVE WAS FOUND NEGATIVE. THE FOLLOWING RESULTS WERE PROVIDED: DONATION FROM (B)(6) 2024: THE INITIAL ELECSYS SYPHILIS RESULT WAS 0.867 COI (NEGATIVE). THE REPEAT ELECSYS SYPHILIS RESULT OF A RETENTION SAMPLE AFTER (B)(6) 2025 WAS 1.32 COI AND 1.32 COI (REPEATEDLY POSITIVE). THE IMMUNOBLOT ANALYSIS (FUJIREBIO) WAS POSITIVE. DONATION FROM 30-MAY-2025: THE ELECSYS SYPHILIS RESULT WAS 1.33 COI, 1.40 COI, AND 1.30 COI (REPEATEDLY POSITIVE). THE IMMUNOBLOT ANALYSIS (FUJIREBIO) WAS INDETERMINATE. THE REPEAT IMMUNOBLOT ANALYSIS (FUJIREBIO) WAS POSITIVE USING ANOTHER ALIQUOT OF THE SAME SAMPLE DONATION THAT WAS PROVIDED ON (B)(6) 2025. ALLEGEDLY, THE SYPHILIS DIAGNOSIS AND ITS TIMING WERE NOT KNOWN TO THE CUSTOMER. REPORTEDLY, THE DONOR HAS BEEN REGULARLY TESTING POSITIVE WITH THE SYPHILIS ELECSYS TEST SINCE (B)(6) 2020, AND THE RESULT OF THE CONFIRMATORY DIAGNOSTICS WAS NEGATIVE. THUS, THE DONOR WAS APPROVED FOR FURTHER DONATIONS.

  Patient problems: Insufficient Information

  MAUDE report 22703558 ↗
• MalfunctionJul 11, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE-NEGATIVE ELECSYS SYPHILIS RESULTS FOR DONOR SAMPLES FROM A COBAS E801 ANALYZER. THE DONOR WAS PROVIDING PLATELET DONATIONS. ON (B)(60 2025, THE RESULT WAS 0.118 COI (NON-REACTIVE). ON (B)(6) 2025, THE RESULT WAS 0.409 COI (NON-REACTIVE). THE RESULT USING THE ABBOTT ARCHITECT WAS 2.63 S/CO. NO INTERPRETATION WAS PROVIDED. THE REPEAT RESULT USING A COBAS E602 ANALYZER WITH REAGENT LOT 828482 WAS 0.382 COI (NON-REACTIVE). ON (B)(6) 2025, THE RESULT WAS 10.5 COI (REACTIVE). THE RESULT USING THE ABBOTT ARCHITECT WAS 12.37 S/CO. NO INTERPRETATION WAS PROVIDED. THE REPEAT RESULT USING A COBAS E602 ANALYZER WITH REAGENT LOT 828482 WAS 7.53 COI (REACTIVE). ADDITIONAL INFORMATION WAS PROVIDED THAT, USING A DIFFERENT ABBOTT ANALYZER AND ALSO DIASORIN LIASON, THE SYPHILIS RESULTS WERE FOUND POSITIVE. NO SPECIFIC DATA WAS PROVIDED. DUE TO THE LIMITED INFORMATION AVAILABLE, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL SAMPLES INVOLVED IN THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22479264 ↗
• InjuryJul 11, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE NEGATIVE ELECSYS SYPHILIS RESULTS FOR APHERESIS PLATELET DONATION FROM ONE PATIENT. THE CUSTOMER USED A COBAS E801 ANALYZER. ON (B)(6) 2025, THE RESULT WAS REPORTED TO BE 0.159 COI (NON-REACTIVE). THE RESULT USING THE ABBOTT ARCHITECT WAS REPORTED TO BE 0.15 S/CO. NO INTERPRETATION WAS PROVIDED. ON (B)(6) 2025, THE RESULT WAS REPORTED TO BE 0.772 COI (NON-REACTIVE). THE RESULT USING THE ABBOTT ARCHITECT WAS REPORTED TO BE 3.64 S/CO. NO INTERPRETATION WAS PROVIDED. ON (B)(6) 2025, THE RESULT WAS REPORTED TO BE 2.19 COI (REACTIVE). THE RESULT USING THE ABBOTT ARCHITECT WAS REPORTED TO BE 6.87 S/CO. NO INTERPRETATION WAS PROVIDED. ON (B)(6) 2025, THE RESULT WAS REPORTED TO BE 14.8 COI (REACTIVE). THE RESULT USING THE ABBOTT ARCHITECT WAS REPORTED TO BE 12.02 S/CO. NO INTERPRETATION WAS PROVIDED. ALLEGEDLY, AT THE TIME OF THE REACTIVE RESULT ON (B)(6) 2025, THE TWO PLATELET DONATIONS HAD ALREADY BEEN TRANSFUSED INTO TWO PATIENTS ON (B)(6) 2025. AN INITIAL BLOOD TEST OF THE RECIPIENTS REPORTEDLY SHOWED NO EVIDENCE OF A SYPHILIS INFECTION. REPORTEDLY, A SECOND TESTING OF THE RECIPIENTS IS PLANNED IN APPROXIMATELY EIGHT WEEKS. DUE TO THE LIMIT

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

  MAUDE report 22479258 ↗
• MalfunctionJul 2, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER QUESTIONED NEGATIVE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS SYPHILIS (SYPHILIS) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A TREPONEMA PALLIDUM PARTICLE AGGLUTINATION (TPPA) TEST. THE INITIAL RESULT FROM THE E801 ANALYZER WAS 0.78 COI (NEGATIVE). THE REPEAT FROM THE E801 ANALYZER WAS 0.81 COI (NEGATIVE). THE RESULT FROM THE TPPA TEST WAS POSITIVE. THE POSITIVE RESULT WAS BELIEVED TO BE CORRECT. THE QUESTIONABLE NEGATIVE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383410 ↗
• MalfunctionJan 31, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS SYPHILIS RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE PATIENT'S RESULT FROM A REFERRAL LABORATORY THAT USES AN ABBOTT ALINITY WAS 3.11 S/CO AND 3.22 S/CO (REACTIVE). A NEW PATIENT SAMPLE WAS COLLECTED AND SENT TO THE REPORTER'S ESTABLISHMENT FOR CONFIRMATION. ON (B)(6) 2025: THE INITIAL RESULT FROM THE ANALYZER WAS 0.107 COI (NON-REACTIVE). THE FIRST REPEAT RESULT FROM THE REFERRAL LABORATORY THAT USES AN ABBOTT ALINITY WAS 1.98 S/CO (REACTIVE). ON (B)(6) 2025: THE SECOND REPEAT RESULT FROM ANOTHER COBAS E 801 ANALYZER WAS 0.104 COI (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283992 ↗
• MalfunctionDec 26, 2024False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS SYPHILIS ASSAY ON A COBAS E801 MODULE WHEN COMPARED TO 2 DIFFERENT LABORATORIES. ON (B)(6) 2024: THE SAMPLE WAS INITIALLY TESTED IN ANOTHER LABORATORY AND THE RESULT WAS REACTIVE. ON (B)(6) 2024: THE SAMPLE WAS RE-TESTED AT THE CUSTOMER'S SITE AND THE RESULT WAS 0.0732 COI AND CONSIDERED NON-REACTIVE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AS THE CUSTOMER QUESTIONED THE RESULT. ON (B)(6) 2024: THE SAMPLE WAS REPEATED IN ANOTHER HOSPITAL AND THE RESULT WAS REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020709 ↗
• MalfunctionMay 2, 2024False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SYPHILIS RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2024 THE PATIENT PRODUCED A NON-REACTIVE RESULT. ON (B)(6) 2024 A NEW SAMPLE WAS DRAWN AND THE RESULTS WERE REPEATEDLY REACTIVE WITH AN ALARM AND A FLAG. THE RESULTS WERE 1.01 COI, 1.00 COI, AND 1.02 COI. A REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS AUTOMATICALLY REPEATED AND THE RESULT WAS NONREACTIVE (0.971 COI). THE SAMPLE WAS MANUALLY PROGRAMMED TO REPEAT AND THE RESULT WAS NONREACTIVE (0.979 COI). THE SAMPLE WAS REPEATED AND THE RESULTS WERE "REPEATEDLY REACTIVE" (1.00 COI, 0.997 COI, AND 1.02 COI). THIS SAMPLE FROM (B)(6) 2024 WAS SENT TO ANOTHER LABORATORY FOR CONFIRMATION TESTING, BUT THE RESULTS OF THE CONFIRMATION TEST HAVE NOT BEEN RECEIVED AT THIS TIME. IT IS UNKNOWN WHICH RESULT IS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230097 ↗