Elecsys Toxo IgG 07028008190Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04015630940301), received between Nov 19, 2021 and Aug 13, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “High Test Results” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233557 ↗
• MalfunctionApr 16, 2026False Positive Result; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE-POSITIVE ELECSYS TOXO IGG ASSAY RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 50.6 IU/ML (REACTIVE). THE FIRST REPEAT RESULT ON ANOTHER E801 WAS 13.6 IU/ML. THE SECOND REPEAT RESULT WAS 12.9 IU/ML. IT WAS NOT SPECIFIED WHICH ANALYZER THIS RESULT WAS FROM. THE RESULT OF THE PATIENT'S OTHER SAMPLE ON (B)(6) 2026 WAS < 0.180 IU/ML. THE RESULT OF < 0.180 IU/ML WAS CONSIDERED CORRECT BASED ON THE PATIENT'S MEDICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899622 ↗
• MalfunctionApr 10, 2026False Positive Result; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR THREE SAMPLES COLLECTED FROM THE SAME PATIENT TESTED WITH ELECSYS TOXO IGG AND ELECSYS TOXO IGM ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE TOXO IGG ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOXO IGM ASSAY. ON (B)(6) 2026, A FIRST SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A TOXO IGG VALUE OF 9.3 IU/ML (REACTIVE) AND A TOXO IGM VALUE OF 2.38 COI (REACTIVE). ON (B)(6) 2026, A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A TOXO IGG VALUE OF 8.4 IU/ML (REACTIVE) AND A TOXO IGM VALUE OF 2.36 COI (REACTIVE). ON (B)(6) 2026, A THIRD SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A TOXO IGG VALUE OF 9.0 IU/ML (REACTIVE) AND A TOXO IGM VALUE OF 2.49 COI (REACTIVE). THIS SAMPLE WAS TESTED FOR TOXO IGG AVIDITY AND THE RESULT WAS 66.5 % (AVIDITY LOW). IN THE SAME TIME PERIOD ON UNKNOWN DATES, THE PATIENT HAD FOLLOW UP TESTING AT TWO ADDITIONAL SITES. THE FIRST SITE USED A DIASORIN INSTRUMENT AND BOTH TOXO IGG AND TOXO IGM WERE NEGATIVE. THE SECOND SITE USED AN AUTOBIO INSTRUMENT AND RESULTED IN A NEGATIVE TOXO IGG VALUE, A NEGATIVE TOXO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840059 ↗
• MalfunctionApr 3, 2026High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOXO IGG RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE RESULTS FROM THE ANALYZER WERE POSITIVE. THE RESULTS FROM ANOTHER ANALYZER WERE NEGATIVE. THE REPORTER STATED THAT RERUNS WITH THE ANALYZER YIELD NO RESULTS, BUT WHEN RERUN USING A DIFFERENT BRAND OF TEST TUBE, THE CLINICAL INTERPRETATION CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779989 ↗
• MalfunctionMar 16, 2026High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED FALSE POSITIVE ELECSYS TOXO IGG RESULTS FOR SAMPLES FROM TWO PATIENTS TESTED ON A COBAS E 801 MODULE. ON (B)(6) 2025, A FIRST SAMPLE FROM THE FIRST PATIENT RESULTED IN A TOXO IGG VALUE OF 44.20 IU/ML (REACTIVE). ON (B)(6) 2025, A SECOND SAMPLE FROM THE FIRST PATIENT RESULTED IN A TOXO IGG VALUE OF 43.40 IU/ML (REACTIVE). ON (B)(6) 2026, A THIRD SAMPLE COLLECTED FROM THE FIRST PATIENT POSTPARTUM RESULTED IN A TOXO IGG VALUE OF 32.50 IU/ML (REACTIVE). ON (B)(6) 2026, A FIRST SAMPLE COLLECTED FROM THE SECOND PATIENT (DAUGHTER OF FIRST PATIENT), RESULTING IN A TOXO IGG VALUE OF 43.60 IU/ML (REACTIVE). SINCE THE THIRD SAMPLE FROM THE FIRST PATIENT RESULTED IN A TOXO IGG VALUE CLOSE TO THE ASSAY CUTOFF (30 IU/ML), THE (B)(6) 2026 SAMPLES FROM BOTH PATIENTS WERE SENT TO AN EXTERNAL LABORATORY FOR SECONDARY TESTING. THE FIRST PATIENT'S SAMPLE FROM (B)(6) 2026 WAS TESTED USING AN UNKNOWN TOXO IGG CLIA METHOD, RESULTING IN A TOXO IGG VALUE OF < 7 UI/ML (NON-REACTIVE). AN IMMUNOBLOT PERFORMED WITH THIS SAMPLE HAD AN INDETERMINATE TOXO IGG RESULT. THE SECOND PATIENT'S SAMPLE FROM (B)(6) 2026 WAS TESTED USING AN UNKNOWN TOXO IGG CLIA METHOD, RESULTING I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605997 ↗
• MalfunctionJul 29, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGG RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 25.3 UI/ML (REACTIVE) THE SAMPLE WAS TESTED ON A COMPETITOR'S CHEMILUMINESCENCE METHODOLOGY, AND THE RESULT WAS "NEGATIVE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642382 ↗
• MalfunctionFeb 12, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOXO IGG RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE TOXO IGG RESULT WAS 0.19 IU/ML (NEGATIVE). THE PHYSICIAN STATED THAT THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY; A POSITIVE RESULT WAS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363528 ↗
• MalfunctionJan 14, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOXO IGG RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS E 801 MODULE. SAMPLE 1: THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY FOR AVIDITY TESTING. THE LABORATORY USES THE LINE IMMUNE ASSAY (LIA) LABORATORY METHOD. ON (B)(6) 2024: THE INITIAL RESULT FROM THE MODULE WAS 97.4 IU/ML. ON (B)(6) 2024: THE FIRST REPEAT RESULT FROM THE LIA METHOD WAS NEGATIVE. ON (B)(6) 2024: THE SECOND REPEAT RESULT FROM THE LIA METHOD WAS NEGATIVE. SAMPLE 2: THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY FOR AVIDITY TESTING. THE LABORATORY USES AN ABBOTT ANALYZER WITH CHEMILUMINESCENCE MICROPLATE IMMUNOASSAY (CMIA) AS THE LABORATORY METHOD. ON (B)(6) 2024: THE INITIAL RESULT FROM THE MODULE WAS 100.0 IU/ML. ON (B)(6) 2024: THE REPEAT RESULT FROM THE CMIA METHOD WAS 2.3 IUML (BORDERLINE). THE RESULTS FROM (B)(6) 2024 WERE REPORTED TO THE PATIENT. THE PHYSICIAN SUSPECTS AN INTERFERENCE MAY HAVE CAUSED THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148859 ↗
• MalfunctionSep 25, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOXO IGG, ELECSYS ANTI-HBC II, AND ELECSYS HBSAG GEN. 2 IMMUNOASSAY RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT (WITH 3 MODULES: MODULE A, MODULE B, AND MODULE C). THE QUESTIONABLE RESULTS WERE FOUND WHILE THE REPORTER WAS PERFORMING AN INSTRUMENT VALIDATION. THIS MEDWATCH IS FOR THE ELECSYS TOXO IGG ASSAY. PLEASE REFER TO THE MEDWATCH WITH: A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS HBSAG II ASSAY. A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS ANTI-HBC II ASSAY. SAMPLE (B)(6): ON (B)(6) 2024, THE INITIAL TOXO IGG RESULT FROM MODULE A WAS 0.180 IU/ML WITH A DATA FLAG. ON (B)(6) 2024, THE REPEAT RESULT FROM MODULE B WAS 14.6 IU/ML. SAMPLE (B)(6): ON (B)(6) 2024, THE INITIAL TOXO IGG RESULT FROM MODULE C WAS 2.17 IU/ML. THE FIRST REPEAT RESULT FROM MODULE B WAS 2.10 IU/ML. ON (B)(6) 2024, THE SECOND REPEAT RESULT FROM MODULE B WAS 13.5 OR 13.05 IU/ML. THE REPORTER STATED THAT THE REPEAT RESULTS MIGHT BE THE CORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304359 ↗
• MalfunctionMar 26, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOXO IGG ON A COBAS E 801 MODULE. THE SAMPLE INITIALLY RESULTED IN A TOXO IGG VALUE OF 40.6 IU/ML (REACTIVE). THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A NEGATIVE TOXO IGG VALUE. THE SPECIFIC VALUE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977096 ↗
• MalfunctionFeb 29, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGG AND CMV IGG ELECSYS E2G RESULTS FOR 1 PATIENT ON A COBAS 8000 E 801 MODULE. THE SAMPLE FROM (B)(6)2023 PRODUCED THE FOLLOWING RESULTS: THE CMV IGG ELECSYS E2G RESULT WAS <0.25 UI/ML (NON-REACTIVE). THE CMV IGM ELECSYS RESULT WAS 0.12 COI (NON-REACTIVE). ANOTHER METHOD (DIASORIN LIAISONXL ) WAS USED AT A REFERENCE LABORATORY AND THE CMV IGG RESULT WAS <5.0 AU/ML (NEGATIVE). ANOTHER METHOD (DIASORIN LIAISONXL ) WAS USED AT A REFERENCE LABORATORY AND THE CMV IGM RESULT WAS <5.0 AU/ML (NEGATIVE). THE SAMPLE FROM (B)(6) 2023 PRODUCED THE FOLLOWING RESULTS: THE ELECSYS TOXO IGG RESULT WAS < 0.18 UI/ML (NON-REACTIVE). THE ELECSYS TOXO IGM RESULT WAS 0.16 COI (NON-REACTIVE). THE CMV IGG ELECSYS E2G RESULT WAS <0.25 UI/ML (NON-REACTIVE). THE CMV IGM ELECSYS RESULT WAS 0.12 COI (NON-REACTIVE). ANOTHER METHOD (DIASORIN LIAISONXL ) WAS USED AT A REFERENCE LABORATORY AND THE TOXOPLASMA IGG RESULT WAS 0 UI/ML (NEGATIVE). ANOTHER METHOD (DIASORIN LIAISONXL ) WAS USED AT A REFERENCE LABORATORY AND THE TOXOPLASMA IGM RESULT WAS <3.00 INDEX (NEGATIVE). THE WESTERNBLOT TOXO IGG (LDBIO DIAGNOSTICS METHOD) OVERALL INTERPRETATION OF THE RESULT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809483 ↗
• MalfunctionJul 19, 2023False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT A QUESTIONABLE HIGH RESULT FOR 1 PATIENT'S SERUM SAMPLE TESTED WITH ELECSYS TOXO IGG ASSAY ON A COBAS E 801 IMMUNOANALYZER WHEN COMPARED TO A NON-ROCHE (DIASORIN LIAISON XL) TOXO IGG. ON (B)(6) 2023: INITIAL RESULT: 69.4 IU/ML (REACTIVE). REPEAT RESULT: 3.0 IU/ML (DIASORIN LIAISON XL, NON-REACTIVE). NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17355204 ↗
• MalfunctionJun 5, 2023High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TOXO IGG (TOXO IGG) ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2023 THE PATIENT HAD A TOXO IGG RESULT FROM THE E801 ANALYZER OF < 1 IU/ML (NEGATIVE). THE TOXO IGM RESULT WAS 0.22 COI (NEGATIVE). ON (B)(6) 2023 A NEW SAMPLE WAS OBTAINED AND THE TOXO IGG RESULT FROM THE E801 ANALYZER WAS 20 IU/ML (POSITIVE). THE TOXO IGM RESULT WAS 0.24 COI (NEGATIVE). DUE TO THE DIFFERENCE BETWEEN THE 2 SAMPLES FOR TOXO IGG, BOTH SAMPLES WERE REPEATED AND THE RESULTS FROM EACH SAMPLE WERE REPRODUCIBLE: THE TOXO IGG RESULT FROM THE SAMPLE OBTAINED ON (B)(6) 2023 WAS NEGATIVE. THE TOXO IGG RESULT FROM THE SAMPLE OBTAINED ON (B)(6) 2023 WAS 20 IU/ML (POSITIVE). THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. DUE TO SUSPICIONS OF A RECENT INFECTION, THE DOCTOR REQUESTED REPEAT TESTING. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY WHERE THE TOXO IGG RESULT FROM THE ROCHE METHOD WAS 19.44 IU/ML (POSITIVE). THE TOXOPLASMA IGG AVIDITY RESULT WAS HIGH. AS THE AVIDITY RESULT DID NOT CORRESPOND TO A RECENT INFECTION, THE SAMPLE FROM (B)(6) 2023 WAS SENT TO A REFERENCE LABORATORY: THE TOXOPLASMOSIS IGG R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064880 ↗
• MalfunctionApr 10, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED THEY RECEIVED A FALSE POSITIVE RESULT FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOXO IGG ON COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE COMPLAINED SAMPLE RESULTED IN A TOXO IGG VALUE OF 4.94 IU/ML (REACTIVE) AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO A PHYSICIAN. THE PHYSICIAN REQUESTED A NEW SAMPLE TO BE COLLECTED FROM THE PATIENT. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED ON (B)(6) 2023, RESULTING IN A TOXO IGG VALUE OF 0.180 IU/ML (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708388 ↗
• MalfunctionJan 17, 2023High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TOXO IGG (TOXO IGG) ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2022 THE PATIENT HAD A TOXO IGG RESULT FROM A NON-ROCHE METHOD OF 2.1 UI/ML (NEGATIVE). THE RESULT FROM THE E801 MODULE WAS APPROXIMATELY 40 IU/ML (POSITIVE). ON (B)(6) 2022 THE PATIENT HAD A TOXO IGG RESULT FROM A NON-ROCHE METHOD OF 2.3 IU/ML (NEGATIVE). THE RESULT FROM THE E801 MODULE WAS 42 IU/ML (POSITIVE). WESTERN BLOT TESTING WAS PERFORMED ON THIS SAMPLE AND THE PRESENCE OF IGG WAS NOT CONFIRMED. ON (B)(6) 2022 THE RESULT FROM THE E801 MODULE WAS 39.6 IU/ML (POSITIVE). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E801 ANALYZER SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185801 ↗
• MalfunctionDec 14, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGG IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO AN ABBOTT ALINITY ANALYZER AND A BIOMÉRIEUX VIDAS ANALYZER. ON (B)(6) 2022, THE INITIAL TOXO IGG RESULT WAS 50.70 IU/ML, INTERPRETED AS REACTIVE. ON (B)(6) 2022, THE SAMPLE WAS REPEATED AND THE RESULT WAS 56.90 IU/ML, INTERPRETED AS REACTIVE. THE SAMPLE WAS TESTED ON AN ABBOTT ALINITY ANALYZER AND THE RESULT WAS 1.4 IU/ML, INTERPRETED AS NON-REACTIVE. THE SAMPLE WAS ALSO TESTED ON A BIOMÉRIEUX VIDAS ANALYZER AND THE RESULT WAS 2 IU/ML, INTERPRETED AS NON-REACTIVE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E801 SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978366 ↗
• MalfunctionNov 29, 2022High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS TOXO IGG (TOXO IGG) ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2022 PATIENT 1 (ID (B)(6)) RESULT FROM THE E801 ANALYZER WAS 82.1 IU/ML (POSITIVE). THE RESULT FROM THE VIDAS METHOD WAS 6.0 IU/ML (INDETERMINATE). ON (B)(6) 2022 PATIENT 2 (ID (B)(6)) RESULT FROM THE E801 ANALYZER WAS 34.2 IU/ML (POSITIVE) THE RESULT FROM THE LIAISON DIASORIN METHOD WAS < 3.0 IU/ML (NEGATIVE). THE RESULT FROM THE VIDAS (PREDETERMINATION) METHOD WAS 5.0 IU/ML (INDETERMINATE). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E801 ANALYZER SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15881566 ↗
• MalfunctionSep 12, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOXO IGG ON A COBAS 8000 E 801 MODULE. A QUESTIONABLE RESULT FROM THE SAMPLE WAS REPORTED OUTSIDE OF THE LABORATORY TO A MEDIC, WHO REQUESTED A RERUN. THE SAMPLE INITIALLY RESULTED IN A TOXO IGG VALUE OF 11.5 IU/ML (REACTIVE) ON THE E 801 ANALYZER. THE SAMPLE WAS REPEATED ON THE E 801 ANALYZER ON (B)(6) 2022, RESULTING IN A VALUE OF 12.1 IU/ML (REACTIVE). THE SAMPLE WAS SENT TO TWO OTHER LABORATORIES FOR TESTING ON THE VIDAS AND ALINITY PLATFORMS. IT IS NOT KNOWN SPECIFICALLY WHICH PLATFORM WAS USED AT EACH LABORATORY. AT THE FIRST LABORATORY, THE TOXO IGG RESULT WAS < 1 IU/ML (NEGATIVE) ON (B)(6) 2022. AT THE SECOND LABORATORY, THE TOXO IGG RESULT WAS 0.40 IU/ML (NEGATIVE) ON (B)(6) 2022. THE E 801 ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15405902 ↗
• MalfunctionSep 8, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGG RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT, SERIAL NUMBER (B)(4). THE TOXO IGG RESULT WAS NEGATIVE USING THE LIAISON XL DIASORIN METHOD IN A DIFFERENT LABORATORY. A NUMERICAL RESULT WAS NOT PROVIDED. THE ELECSYS TOXO IGG RESULT WAS 66.5 IU/ML (REACTIVE) ON THE E 801 MODULE. IT IS UNKNOWN WHICH RESULT IS BELIEVED TO BE CORRECT. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382532 ↗
• MalfunctionJun 16, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOXO IGG RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). ON (B)(6) 2022, THE PATIENT'S ELECSYS TOXO IGG RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER QUESTIONED THE ELECSYS TOXO IGG RESULTS AND THE SAMPLE WAS TESTED ON AN ABBOTT ALINITY ANALYZER AND BY WESTERN BLOT. THE PATIENT HAD AN ADDITIONAL SAMPLE COLLECTED ON (B)(6) 2022 FOR TESTING WITH THE ELECSYS TOXO IGG REAGENT ON AN E 801 MODULE AND BY WESTERN BLOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712449 ↗
• MalfunctionDec 30, 2021False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TOXO IGG IMMUNOASSAY ON A COBAS 8000 E 801 MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS INITIALLY TESTED ON THE E 801 ANALYZER, BUT THERE WAS NO VALUE, ONLY A FLAG INDICATING THERE WAS A SAMPLE CLOT. THE SAMPLE WAS REPEATED ON THE E 801 ANALYZER, RESULTING IN A TOXO IGG VALUE OF 50.2 IU/ML (REACTIVE). THE SAMPLE WAS REPEATED ON A BIOMNIS ANALYZER, RESULTING IN A VALUE OF < 6.1 (NEGATIVE, NO UNITS PROVIDED). THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120292 ↗
• MalfunctionNov 19, 2021High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE HIGH ELECSYS TOXO IGG IMMUNOASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). THE PATIENT'S ELECSYS TOXO IGG RESULTS WERE REPORTED OUTSIDE THE LABORATORY. AFTER A PREVIOUS TREATMENT WITH IMMUNOGLOBULINS, THE PATIENT'S PHYSICIAN QUESTIONED THE HIGH TOXO IGG RESULTS FROM THE SAMPLE COLLECTED ON (B)(6) 2021. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE PATIENT'S SAMPLE. ALSO, THE PATIENT'S SAMPLE WAS SENT TO TWO DIFFERENT LABORATORIES FOR FURTHER TESTING. ON (B)(6) 2021, THE PATIENT HAD A NEW SAMPLE COLLECTED. IT WAS REQUESTED BUT NOT PROVIDED IF THE TOXO IGG RESULT WAS QUESTIONED BY THE PHYSICIAN. REFER TO THE ATTACHMENT ON THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843972 ↗