Elecsys Syphilis 07251378190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04015630940356), received between Aug 18, 2021 and Aug 15, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (6 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.

• MalfunctionAug 15, 2025False Negative Result; False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR 2 SAMPLES FROM THE SAME PATIENT TESTED WITH ELECSYS SYPHILIS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1 WAS TESTED IN A DIFFERENT LABORATORY, AND THE RESULT WAS POSITIVE. SAMPLE 1 WAS THEN REPEATED WITH ELECSYS SYPHILIS AT THE CUSTOMER'S SITE, RESULTING IN A NEGATIVE VALUE. THE DATES OF TESTING WERE NOT PROVIDED, AND THEREFORE, THE SPECIFIC DATE OF EVENT IS UNKNOWN. SAMPLE 2 WAS TESTED ON (B)(6) 2025, RESULTING IN AN INITIAL ELECSYS SYPHILIS RESULT OF 0.0709 COI (INTERPRETED AS NON-REACTIVE). SAMPLE 2 WAS REPEATED ON (B)(6) 2025, RESULTING IN THE FOLLOWING: 1ST REPEAT RESULT: 1.55 INDEX (TESTED ON ABBOTT SYPHILIS TP AND INTERPRETED AS POSITIVE). 2ND REPEAT RESULT: NEGATIVE (TESTED ON SYPHILIS VDRL). IMMUNO BLOT IGG RESULT: ONLY THE SPECIFIC PROTEIN OF TPN15 WAS PRESENT AND WAS INTERPRETED AS INDETERMINATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819312 ↗
• MalfunctionApr 28, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR THREE SAMPLES FROM THE SAME PATIENT TESTED WITH ELECSYS SYPHILIS ON A COBAS E 801 ANALYTICAL UNIT. NEGATIVE VALUES WERE OBTAINED ON THE E 801 ANALYZER, BUT COMPETITOR SYSTEMS SHOWED POSITIVE VALUES. NO UNITS OF MEASURE WERE PROVIDED FOR THE COMPETITOR RESULTS. THE FIRST SAMPLE RESULTED IN SYPHILIS VALUES OF 0.53 COI (NON-REACTIVE) AND 0.471 COI (NON-REACTIVE) WHEN TESTED ON THE E801 ANALYZER. THE SAMPLE WAS REPEATED USING THE LIAISON METHOD, RESULTING IN A VALUE OF 6.53. THE SAMPLE WAS REPEATED USING THE TPHA FORTRESS METHOD, RESULTING IN AN "EQUIVOCAL" VALUE. THE SAMPLE WAS REPEATED USING THE RPR AIX METHOD, RESULTING IN A VALUE OF 1:4. THE SECOND SAMPLE RESULTED IN A SYPHILIS VALUE OF 0.688 (NON-REACTIVE) WHEN TESTED ON THE E801 ANALYZER ON (B)(6) 2025. THE SAMPLE WAS REPEATED USING THE LIAISON METHOD, RESULTING IN A VALUE OF 10.3. THE SAMPLE WAS REPEATED USING THE TPHA FORTRESS METHOD, RESULTING IN A "DETECTED" VALUE. THE THIRD SAMPLE RESULTED IN SYPHILIS VALUES OF 0.61 COI (NON-REACTIVE) AND 0.615 (NON-REACTIVE) WHEN TESTED ON THE E801 ANALYZER ON (B)(6) 2025. THE SAMPLE WAS REPEATED USING THE LIAISON METHOD, RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918244 ↗
• MalfunctionJan 14, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SYPHILIS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE RESULT WAS 0.093 COI (NON-REACTIVE). THE RESULT BY FLUORESCENT ANTIBODY IGM WAS POSITIVE FOR SYPHILIS. THE RESULT BY SYPHILIS FLUORESCENT ANTIBODY IGG WAS NEGATIVE. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149206 ↗
• MalfunctionApr 18, 2024False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF A FALSE NEGATIVE ELECSYS SYPHILIS RESULT FOR ONE PATIENT FROM THE COBAS 8000 CORE UNIT. THE PATIENT WAS TESTED WITH COLLOIDAL GOLD METHOD AND THE RESULT WAS 13.468 COI (POSITIVE). A FEW DAYS LATER, THE PATIENT WAS TESTED USING THE ANTU PLATFORM AND THE RESULT WAS 11.751 COI (POSITIVE). USING THE SAME SAMPLE AS THE ANTU TEST, THE PATIENT WAS TESTED USING THE ROCHE METHOD AND THE RESULT WAS 0.0921 COI (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135575 ↗
• MalfunctionDec 15, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THERE WAS AN ALLEGATION OF A QUESTIONABLE SYPHILIS ELECSYS E2G RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE RESULT FROM THE COBAS E801 WAS 0.0892 (NEGATIVE). THE RESULT BY TRUST METHOD (SHANGHAI RONGSHENG) WAS WEAK POSITIVE 1:1. AT ANOTHER SITE, THE RPR RESULT WAS WEAK POSITIVE 1:1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335098 ↗
• MalfunctionOct 30, 2023False Negative Result; False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE NEGATIVE RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS SYPHILIS ASSAY ON TWO COBAS 8000 COBAS E801 IMMUNOASSAY ANALYZERS WHEN COMPARED TO COBAS C501 AND C502 RAPID PLASMA REAGIN (RPR). THE CUSTOMER'S LABORATORY: COBAS 8000: COBAS C501 RPR: 1ST RUN: POSITIVE (2.88 ACCOMPANIED WITH A DATA FLAG). 2ND RUN: POSITIVE (38.77 ACCOMPANIED WITH A DATA FLAG, AND TESTED WITH A DECREASE DILUTION). COBAS C502 RPR: 1ST RUN: POSITIVE. 2ND RUN: POSITIVE. TWO COBAS E801: 1ST RUN: 0.213: NEGATIVE (LINE A E801). 2ND RUN: 0.114: NEGATIVE (LINE C E801). 3RD RUN: 0.0956: NEGATIVE (LINE A E801). MANUAL RPR: NEGATIVE (1:128 FOLD). SERODIA TREPONEMA-PALLIDUM PARTICLE AGGLUTINATION (TPPA): POSITIVE. THE FIELD SERVICE ENGINEER (FSE) BROUGHT THE SAMPLE TO ANOTHER LABORATORY FOR FURTHER CROSS-CHECKING. COBAS E801: 1ST RUN: NEAT SAMPLE: 0.0963: NEGATIVE. 2ND RUN: 0.106: NEGATIVE (1:10 MANUAL DILUTION). MANUAL RPR: 1ST RUN: POSITIVE (TESTED WITH 1:1 DILUTION). 2ND RUN: WEAK POSITIVE (TESTED WITH 1:2 DILUTION). 3RD RUN: NEGATIVE (TESTED WITH 1:4 DILUTION). 4TH RUN: NEGATIVE (TESTED WITH 1:8 DILUTION). 5TH RUN: NEGATIVE (TESTED WITH 1:16 DILUTION). 6TH RUN: NEGATIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031714 ↗
• MalfunctionAug 18, 2021False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS SYPHILIS RESULT FOR ONE PATIENT SAMPLE WITH THE COBAS E 801 MODULE SERIAL NUMBER UNKNOWN. ON (B)(6) 2021, THE INITIAL RESULT FROM A BLOOD DONATION WAS 0.978 COI (NON-REACTIVE). THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2021, THE PATIENT MADE ANOTHER BLOOD DONATION WITH A RESULT OF 34.2 COI (REACTIVE). THE SAMPLE WAS REPEATED WITH AN ABBOTT ARCHITECT WITH A RESULT OF 15.04 S/CO (REACTIVE). AFTER THE REACTIVE RESULTS FROM (B)(6) 2021, THE SAMPLE FROM (B)(6) 2021 WAS TESTED FURTHER. THE ABBOTT ARCHITECT RESULT WAS 0.18 S/CO (NON-REACTIVE). THE TPPA 1:640 WAS POSITIVE, FTA ABS IGG >1:10 WAS POSITIVE, AND FTA ABS IGM 1:80 WAS POSITIVE.

  Patient problems: Insufficient Information

  MAUDE report 12338826 ↗