Elecsys Toxo IgM 07028024190Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 04015630940318), received between Jan 25, 2019 and May 1, 2026 — classified as 42 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (32 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS TOXO IGM ASSAY ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1 (SAMPLE 1): THE INITIAL RESULT WAS 1.96 COI (ACCOMPANIED BY A DATA FLAG AND INTERPRETED AS REACTIVE). PATIENT 2 (SAMPLE 2) WAS TESTED ON (B)(6) 2026: THE INITIAL RESULT WAS 1.53 COI (ACCOMPANIED BY A DATA FLAG AND INTERPRETED AS REACTIVE). THE INITIAL RESULTS DID NOT MATCH THE PATIENTS' HISTORY. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. SAMPLE 1 AND SAMPLE 2 WERE THEN REPEATED AT A DIFFERENT LABORATORY USING VIDAS EQUIPMENT AND A DIFFERENT ASSAY METHODOLOGY, AND THE REPEAT RESULTS WERE BOTH NON-REACTIVE. THE CUSTOMER WAS LEANING TOWARDS BELIEVING THAT THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. SAMPLE 2 WAS ALSO RETESTED AT A DIFFERENT LABORATORY USING ROCHE EQUIPMENT, AND THE REPEAT RESULT WAS NON-REACTIVE. A CLARIFICATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058360 ↗
• MalfunctionApr 21, 2026False Positive Result

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS TOXO IGM (TOXO IGM) ON A COBAS E 402 ANALYTICAL UNIT. THE CUSTOMER ALLEGED POSITIVE RESULTS FROM (B)(6) 2026 ("1460 UI/ML"), (B)(6) 2026 ("1430 UI/ML"), AND (B)(6) 2026 ("1360 UI/ML"). THE CUSTOMER ALLEGED THAT SUBSEQUENT TOXO IGM RESULTS FROM AN EXTERNAL LABORATORY FROM AN UNSPECIFIED ENZYME-LINKED FLUORESCENT ASSAY (ELFA) ON (B)(6) 2026 WERE NEGATIVE ("0.07 VT"). DATA WAS PROVIDED FOR ONE SAMPLE TESTED FOR TOXO IGM: ON (B)(6) 2026, THE RESULT ON THE E402 ANALYZER WAS 1.43 COI (POSITIVE). IT IS NOT CLEAR IF THE INITIAL RESULTS PROVIDED ARE FROM ONE PATIENT OR DIFFERENT PATIENTS. THE SPECIFIC INITIAL RESULTS PROVIDED ARE ALSO BEING CLARIFIED. CLARIFICATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943827 ↗
• MalfunctionApr 10, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGM RESULTS FOR MULTIPLE PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER ALLEGED THAT THERE HAVE BEEN PATIENT SAMPLES WITH POSITIVE RESULTS, BUT WHEN TESTED ON OTHER ANALYZERS, THE RESULTS ARE NEGATIVE. NO SPECIFIC RESULTS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839717 ↗
• MalfunctionNov 24, 2025False Negative Result; False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR 2 SAMPLES FROM 1 PATIENT TESTED WITH ELECSYS TOXO IGM ASSAY ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: ELECSYS TOXO IGM ECLIA RESULT: 0.77 COI AND INTERPRETED AS NON-REACTIVE. VIDAS TOXO IGM (ELFA) RESULT: 0.68. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. INTERPRETED AS INDETERMINATE. SAMPLE 2 WAS TESTED ON (B)(6) 2025: ELECSYS TOXO IGM RESULT: 0.49 COI AND INTERPRETED AS NON-REACTIVE. VIDAS TOXOPLASMOSIS IGM (ELFA) RESULT: 0.56. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. INTERPRETED AS INDETERMINATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638039 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGM RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 4.26 COI (REACTIVE). ON (B)(6) 2025, THE REPEAT RESULT WAS 4.15 COI (REACTIVE). THE SAMPLE WAS TESTED IN ANOTHER LABORATORY ON A COMPETITOR'S CHEMILUMINESCENCE METHODOLOGY, AND THE RESULT WAS "NEGATIVE". THE TOXO IGM RESULT OBTAINED IN THE OTHER LABORATORY WAS CONSIDERED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642355 ↗
• MalfunctionJul 17, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGM RESULTS FOR 2 PATIENTS ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1 ON (B)(6) 2025: THE ELECSYS TOXO IGM RESULTS WERE 1.37 COI (REACTIVE) AND 1.25 COI (REACTIVE). THE ELECSYS TOXO IGG RESULT WAS NON-REACTIVE. THE AVIDITY IGG RESULT WAS LOW AVIDITY. THE TOXO IGM RESULT USING ANOTHER METHOD WAS 0.06 (NON-REACTIVE). SAMPLE 2 (TWO DIFFERENT SAMPLES FROM THE SAME PATIENT) ON (B)(6) 2025: THE ELECSYS TOXO IGM RESULTS WERE 1.44 COI (REACTIVE) AND 1.40 COI (REACTIVE). THE ELECSYS TOXO IGG RESULT WAS NON-REACTIVE. ON (B)(6) 2025: THE ELECSYS TOXO IGM RESULT WAS 1.30 COI (REACTIVE). THE ELECSYS TOXO IGG RESULTS WAS NON-REACTIVE. THE TOXO IGM RESULT USING ANOTHER METHOD WAS 0.05 COI (NON-REACTIVE). THE TOXO IGG RESULT USING ANOTHER METHOD WAS 0.2 IU/ML (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529754 ↗
• MalfunctionJul 15, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS TOXO IGM ON A COBAS E 801 ANALYTICAL UNIT. THE RESULTS WERE NEGATIVE, BUT CLINICIANS FLAGGED THESE PATIENTS AS LIKELY POSITIVE BASED ON PREVIOUS POSITIVE REPORTS FROM ANOTHER LABORATORY. THE FIRST SAMPLE RESULTED IN A TOXO IGM VALUE OF 0.29 COI (NON-REACTIVE) ON THE E801 ANALYZER. THE SAMPLE WAS REPEATED USING THE VIDAS TOXO IGM METHOD, RESULTING IN A VALUE OF 0.74 INDEX (REACTIVE). THE SAMPLE WAS ALSO TESTED USING THE LIAISON TOXO IGM METHOD, AND THE RESULT WAS 28.4 INDEX (REACTIVE). THE SECOND SAMPLE RESULTED IN A TOXO IGM VALUE OF 0.468 COI (NON-REACTIVE) ON THE E801 ANALYZER ON (B)(6) 2025. THE SAMPLE WAS REPEATED USING THE VIDAS TOXO IGM METHOD, RESULTING IN A VALUE OF 0.92 INDEX (REACTIVE). THE SAMPLE WAS ALSO TESTED USING THE LIAISON TOXO IGM METHOD, AND THE RESULT WAS 21.2 INDEX (REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507772 ↗
• MalfunctionMay 9, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGM RESULTS FOR 1 PATIENT ON A COBAS 8000 E 801 MODULE. THE ELECSYS TOXO IGM RESULT WAS 0.413 COI (NEGATIVE). THE TOXO IGG RESULT WAS >650 IU/ML (POSITIVE). THE ELECSYS TOXO IGG AVIDITY SHOWED LOW AVIDITY. THE SAMPLE WAS TESTED USING THE VIDAS (ELFA) METHOD, AND THE TOXO IGM RESULT WAS 0.83 (POSITIVE). THE UNIT OF MEASURE FOR THIS RESULT WAS NOT PROVIDED. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993034 ↗
• MalfunctionApr 21, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER ALLEGED THEY RECEIVED A QUESTIONABLE POSITIVE RESULT FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOXO IGM ON A COBAS E 801 ANALYTICAL UNIT. THE PATIENT SAMPLE ALLEGEDLY RESULTED IN A TOXO IGM VALUE OF 1.31 COI (POSITIVE) WHEN TESTED ON THE E 801 ANALYZER. THE PATIENT WAS THEN TESTED AT ANOTHER LABORATORY USING AN UNKNOWN METHOD AND THE TOXO IGM VALUE FROM THE OTHER LABORATORY WAS ALLEGEDLY NEGATIVE. A SPECIFIC RESULT WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21872034 ↗
• MalfunctionApr 1, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TOXO IGM (TOXO IGM) BETWEEN 2 COBAS E 801 ANALYTICAL UNITS (MODULE 3 AND MODULE 2) WHILE USING A PARTICULAR REAGENT LOT. THE INITIAL RESULT FROM MODULE 3 USING REAGENT LOT 824690 WAS 1.15 COI (POSITIVE). THE REPEAT RESULT FROM MODULE 2 USING REAGENT LOT 799708 (EXPIRATION 31-MAY-2025) WAS 0.472 COI (NEGATIVE). ON (B)(6) 2025 THE SAMPLE WAS REPEATED ON MODULE 2 USING REAGENT LOT 799708 AND THE RESULT WAS 0.471 COI (NEGATIVE). THE SAMPLE WAS REPEATED ON MODULE 3 USING REAGENT LOT 824690, AND THE RESULT WAS 1.13 COI (POSITIVE). ON (B)(6) 2025 THE SAMPLE WAS REPEATED ON MODULE 3 USING REAGENT LOT NUMBER 799708, AND THE RESULT WAS 0.474 COI (NEGATIVE). THE SAMPLE WAS REPEATED ON MODULE 2 USING REAGENT LOT NUMBER 799708, AND THE RESULT WAS 0.456 COI (NEGATIVE). THE SAMPLE WAS REPEATED ON MODULE 3 USING REAGENT LOT NUMBER 799708, AND THE RESULT WAS 0.486 COI (NEGATIVE). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739607 ↗
• MalfunctionSep 27, 2024False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGM RESULTS FOR 2 PATIENTS ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE INITIAL ELECSYS TOXO IGM RESULT WAS 1.22 COI (REACTIVE). THE REPEATED RESULT WAS 1.20 COI (REACTIVE). IT WAS REPORTED THAT THE SAMPLE WAS TESTED USING ANOTHER METHOD (UNKNOWN) AND THE RESULT WAS NON-REACTIVE. NO ADDITIONAL INFORMATION REGARDING THE NON-REACTIVE RESULT WAS PROVIDED. PATIENT 2: THE DATE THIS SAMPLE WAS TESTED WAS NOT PROVIDED. THE INITIAL ELECSYS TOXO IGM RESULT WAS REACTIVE. A NUMERICAL VALUE WAS NOT PROVIDED. IT WAS REPORTED THAT THE SAMPLE WAS TESTED USING ANOTHER METHOD (UNKNOWN) AND THE RESULT WAS NON-REACTIVE. NO ADDITIONAL INFORMATION REGARDING THE NON-REACTIVE RESULT WAS PROVIDED. AN INTERFERENCE BETWEEN TOXO IGM AND PREGNANCY WAS SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20325227 ↗
• MalfunctionMay 17, 2024False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGM RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 14.9 COI (REACTIVE). THE REPEAT RESULT WAS REACTIVE. NO NUMERIC RESULT WAS PROVIDED. ON (B)(6) 2024, THE SAME SAMPLE WAS TESTED USING DIASORIN LIAISON TOXO IGM AND THE RESULT WAS <3.0 S/CO (NON-REACTIVE). ON (B)(6) 2024, THE SAME SAMPLE WAS TESTED USING ABBOTT ALINITY TOXO IGM AND THE RESULT WAS 0.160 INDEX (NON-REACTIVE). THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340428 ↗
• MalfunctionApr 19, 2024False Negative Result; False Negative Result

  THE INITIAL REPORTER QUESTIONED NEGATIVE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TOXO IGM (TOXO IGM) ON A COBAS 8000 E 801 MODULE AND A COBAS PRO MODULE COMPARED TO POSITIVE RESULTS FROM COMPETITOR METHODS. ON (B)(6) 2024 THE RESULT FROM COMPETITOR METHOD 1 WAS 0.75 INDEX (POSITIVE). ON (B)(6) 2024 THE RESULT FROM COMPETITOR METHOD 2 WAS 8.25 AU/ML (POSITIVE). ON (B)(6) 2024 THE RESULT FROM THE E801 MODULE WAS 0.71 COI (NEGATIVE). ON (B)(6) 2024 THE RESULT FROM THE E801 MODULE WAS 0.746 COI (NEGATIVE). ON (B)(6) 2024 THE RESULT FROM THE COBAS PRO MODULE WAS 0.712 COI (NEGATIVE). ON (B)(6) 2024 THE RESULT FROM COMPETITOR METHOD 3 WAS 1.31 INDEX (POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19145387 ↗
• MalfunctionFeb 6, 2024False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF FALSE POSITIVE ELECSYS TOXO IGM RESULTS FOR 1 PATIENT ON A COBAS E 801 MODULE. THE ELECSYS TOXO IGM RESULT WAS 5.45 COI (REACTIVE). THIS SAMPLE WAS ALSO TESTED ON ANOTHER E801 MODULE AND THE RESULT WAS THE SAME. THE ELECSYS TOXO IGG RESULT WAS<0.180 IU/ML (NON-REACTIVE). THE TOXO IGM RESULT IN A REFERENCE LABORATORY (USING AN ISAGA BIOMÉRIEUX ASSAY) WAS REPORTEDLY NON-REACTIVE. THE NUMERIC RESULT WAS NOT PROVIDED. THE TOXO IGM RESULT IN THE REFERENCE LABORATORY (USING A LIAISON DIASORIN ASSAY) WAS REPORTEDLY <3.0 INDEX (NON-REACTIVE). THE TOXO IGG RESULT IN THE REFERENCE LABORATORY (USING A LIAISON DIASORIN ASSAY) WAS REPORTEDLY 0.169 IU/ML (NON-REACTIVE). ANOTHER SAMPLE FROM THIS PATIENT COLLECTED ON (B)(6) 2024, WAS 5.36 COI (REACTIVE) ON ELECSYS TOXO IGM RESULT. THIS SAMPLE WAS TESTED USING TWO DIFFERENT E801 MODULES. THE RESULTS WERE THE SAME. THE ELECSYS TOXO IGG RESULT WAS <0.180 IU/ML (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650104 ↗
• MalfunctionDec 18, 2023False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOXO IGM ELECSYS E2G RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.27 COI (REACTIVE). ON (B)(6), THE REPEAT RESULTS WERE 1.27 COI (REACTIVE) AND 1.28 COI (REACTIVE). ON (B)(6) 2023, THE SAMPLE WAS RE-CENTRIFUGED AND TESTED ON ANOTHER COBAS E801 ANALYZER USING REAGENT LOT 712936 AND THE RESULT WAS (B)(4) COI (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347466 ↗
• MalfunctionDec 11, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOXO IGM (TOXO IGM) RESULTS FROM 27 PATIENT SAMPLES TESTED ON THE COBAS 8000 E 801. THE REPORTER STATED THAT THEY OBSERVED AN INCREASED NUMBER OF LOW-POSITIVE RESULTS. THEY THEN COMPARED THE RESULTS WITH ANOTHER UNKNOWN METHODOLOGY. THE REPORTER WAS ABLE TO PROVIDE 14 PATIENT SAMPLES WITH DISCREPANT RESULTS. PLEASE REFER TO THE ATTACHMENT (B)(4) FOR THESE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301691 ↗
• MalfunctionNov 1, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER QUESTIONED A POSITIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TOXO IGM (TOXO IGM) ON A COBAS E 402 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. THE RESULT FROM THE E402 ANALYZER WAS 1.1 (POSITIVE). THE RESULT FROM THE COMPETITOR METHOD WAS <0.55 (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046515 ↗
• MalfunctionOct 16, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED THIRTY-THREE QUESTIONABLE ELECSYS TOXO IGM (TOXO IGM) RESULTS FROM PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE PATIENT SAMPLES WERE RERUN USING A CHEMILUMINESCENCE LABORATORY METHOD. PLEASE REFER TO THE ATTACHMENT PT-(B)(4) FOR THE TABLE CONTAINING THE EXAMPLES OF QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17941117 ↗
• MalfunctionOct 13, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE POSITIVE ELECSYS TOXO IGM (TOXO IGM) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. THE REPORTER STATED THAT THEY REPORTED A FALSE POSITIVE RESULT TO MEDICAL PERSONNEL. THE SPECIFIC RESULT WAS NOT PROVIDED. FURTHER INFORMATION AND DATA RELATED TO THIS EVENT WAS REQUESTED BUT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17932286 ↗
• MalfunctionSep 21, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 6 PATIENT SAMPLES TESTED FOR ELECSYS TOXO IGM (TOXO IGM) ON A COBAS E801 MODULE. OF THE DATA PROVIDED, THE RESULTS FOR 4 PATIENT SAMPLES WERE DISCREPANT WHEN COMPARED TO A COMPETITOR CHEMILUMINESCENT IMMUNOASSAY (CLIA) METHOD. PATIENT ID (B)(6) RESULT FROM THE E801 MODULE WAS 1.28 COI (POSITIVE). THE RESULT FROM THE COMPETITOR INSTRUMENT WAS LESS THAN 3 UA/ML (NEGATIVE). PATIENT ID (B)(6) RESULT FROM THE E801 MODULE WAS 1.13 COI (POSITIVE). THE RESULT FROM THE COMPETITOR INSTRUMENT WAS LESS THAN 3 UA/ML (NEGATIVE). PATIENT ID (B)(6) RESULT FROM THE E801 MODULE WAS 0.86 COI (INDETERMINATE). THE RESULT FROM THE COMPETITOR INSTRUMENT WAS LESS THAN 3 UA/ML (NEGATIVE). PATIENT ID (B)(6) RESULT FROM THE E801 MODULE WAS 2.76 COI (POSITIVE). THE RESULT FROM THE COMPETITOR INSTRUMENT WAS 5 UA/ML (NEGATIVE). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789393 ↗
• MalfunctionAug 30, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR "SEVERAL" PATIENT SAMPLES TESTED FOR ELECSYS TOXO IGM (TOXO IGM) ON A COBAS E801 MODULE. DATA WAS PROVIDED FOR 37 PATIENT SAMPLES TESTED BETWEEN (B)(6) 2023 AND (B)(6) 2023. OF THIS DATA, THE RESULTS FOR 33 PATIENT SAMPLES WERE POSITIVE (RESULTS GREATER THAN 1.0 COI). THE CUSTOMER ALLEGEDLY BELIEVES THE RESULTS ARE FALSELY POSITIVE IF NO EVOLUTION IS SEEN IN THE IGM OR IGG RESULTS AFTER MORE THAN 14 DAYS OR IF THE TOXO IGM RESULT FROM A DIFFERENT METHOD IS NEGATIVE. NO COMPARISON DATA WAS PROVIDED. THE FOLLOWING ARE EXAMPLES OF POSITIVE RESULTS FOR 3 PATIENT SAMPLES: ON (B)(6) 2023 PATIENT 1 (ID (B)(6)) RESULT WAS REPORTEDLY 2.66 COI (POSITIVE). ON (B)(6) 2023 PATIENT 2 (ID (B)(6)) RESULT WAS REPORTEDLY 5.61 COI (POSITIVE). ON (B)(6) 2023 PATIENT 3 (ID (B)(6)) RESULT WAS REPORTEDLY 1.13 COI (POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652616 ↗
• MalfunctionJun 16, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE POSITIVE RESULTS FOR THREE SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH THE ELECSYS TOXO IGM ASSAY ON A COBAS E 801 ANALYTICAL UNIT, SERIAL NUMBER (B)(6). FIRST SAMPLE, COLLECTED ON (B)(6) 2023 AND TESTED WITH TOXO IGM REAGENT LOT 652164: ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN A TOXO IGM VALUE OF 2.43 COI (REACTIVE). SECOND SAMPLE, COLLECTED ON (B)(6) 2023 AND TESTED WITH TOXO IGM REAGENT LOT 671956: ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN A TOXO IGM VALUE OF 1.90 COI (REACTIVE). AT AN UNKNOWN DATE, THE SAMPLE WAS ALSO TESTED WITH AN UNKNOWN COMPETITOR CHEMILUMINESCENT ASSAY, RESULTING IN A NON-REACTIVE TOXO IGM RESULT. THIRD SAMPLE, COLLECTED ON (B)(6) 2023 AND TESTED WITH TOXO IGM REAGENT LOT 671956: ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN A TOXO IGM VALUE OF 2.26 COI (REACTIVE). THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145450 ↗
• MalfunctionApr 27, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED, THEY RECEIVED FALSE POSITIVE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ELECSYS TOXO IGM, ON COBAS E 801 MODULE (B)(4). THE CUSTOMER STATED, THEY HAVE BEEN RECEIVING A HIGHER NUMBER OF FALSE POSITIVE PATIENT RESULTS WITH REAGENT LOT 671956 AND ARE SUBMITTING THREE TIMES MORE SAMPLES FOR CONTROL MEASUREMENT. THE FOLLOWING DATA OVERVIEW FOR THE TIME PERIOD OF OCTOBER 2022 UNTIL MARCH 2023 WAS PROVIDED BY THE CUSTOMER: (B)(6) 2022: 20 PATIENT SAMPLES. (B)(6) 2022: 14 PATIENT SAMPLES. (B)(6) 2022: 14 PATIENT SAMPLES. (B)(6) 2023 (PREVIOUS REAGENT LOT): 24 PATIENT SAMPLES. (B)(6) 2023 (STARTING WITH NEW REAGENT LOT): 43 PATIENT SAMPLES. (B)(6) 2023 (REAGENT LOT 6791956): 60 PATIENT SAMPLES. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827694 ↗
• MalfunctionApr 13, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOXO IGM (TOXO IGM) RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS 8000 E 801 MSB/MSBL WITH SERIAL NUMBER (B)(4). THE REPORTER COMPLAINED OF AN INCREASING NUMBER OF BORDERLINE OR WEAKLY POSITIVE RESULTS FOR TOXO IGM WITH THE REPORTED LOT NUMBER. THE PATIENT SAMPLE WAS RERUN USING A DIFFERENT REAGENT LOT NUMBER AND ON A VIDAS ANALYZER. THE REPORTER WAS ABLE TO PROVIDE ONE EXAMPLE OF A QUESTIONABLE RESULT. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT USING REAGENT LOT NUMBER 671956 IS 2.2. THE FIRST REPEAT RESULT FROM THE VIDAS ANALYZER WAS "NEGATIVE". THE SECOND REPEAT RESULT USING REAGENT LOT NUMBER 652164 IS 0.247. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732289 ↗
• MalfunctionApr 11, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED AN INCREASED NUMBER OF BORDERLINE OR WEAKLY POSITIVE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON A PARTICULAR REAGENT LOT OF ELECSYS TOXO IGM (TOXO IGM) ON A COBAS E 801 MODULE. DISCREPANT RESULTS FOR 1 PATIENT SAMPLE WERE PROVIDED. IGM RESULTS: NON-REACTIVE WHEN TESTED ON PREVIOUS SAMPLES, WHILE THE RESULTS WERE OFTEN BORDERLINE OR POSITIVE WHEN TESTED WITH THE PARTICULAR TOXO IGM REAGENT LOT. NO SPECIFIC RESULTS WERE PROVIDED. IT IS NOT KNOWN IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE COBAS E801 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717909 ↗