Elecsys Toxo IgMRecalls & reported problems across all models

We found 2 models of Elecsys Toxo IgM by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Jan 25, 2019 and Sep 3, 2026 — classified as 71 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (58 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 Toxo IgM problems

Elecsys Toxo IgM models

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

• Elecsys Toxo IgM 07028024190

  ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
  42 reports
• Elecsys Toxo IgM 04618858190

  ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
  29 reports

Recent Elecsys Toxo IgM adverse event reports

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

• MalfunctionSep 3, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50592713 ↗
• MalfunctionMay 19, 2026False Positive Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGM ASSAY RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS E 411 ANALYZER (RACK SYSTEM). SAMPLE 1: THE INITIAL RESULTS WERE CONSISTENTLY POSITIVE. THE SAMPLE WAS SENT TO THE EXTERNAL SERVICE LAB AND TESTED ON A LIAISON SYSTEM, WHICH YIELDED NEGATIVE RESULTS. SAMPLE 2: ON (B)(6) 2026, THE INITIAL RESULTS WERE CONSISTENTLY POSITIVE. THE SAMPLE WAS SENT TO THE EXTERNAL SERVICE LAB AND TESTED ON A LIAISON SYSTEM, WHICH YIELDED NEGATIVE RESULTS. DURING THE (B)(6) 2026 TEST, IT WAS CONFIRMED THAT THE QUALITY CONTROL WAS NOT PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215569 ↗
• 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 ↗
• MalfunctionJun 27, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE-POSITIVE ELECSYS TOXO IGM RESULTS FROM THE COBAS E411 DISK ANALYZER. EXAMPLE 1 HAD AN INITIAL RESULT OF 1.2 (REACTIVE). THE PATIENT WAS CHECKED IN ANOTHER LAB USING A DIFFERENT METHOD, AND THE TOXO IGM RESULT WAS NEGATIVE. EXAMPLE 2 HAD AN INITIAL RESULT THAT WAS REACTIVE. THE PATIENT WAS CHECKED IN ANOTHER LAB USING THE ABBOTT METHOD, AND THE TOXO IGM RESULT WAS NEGATIVE. NO SPECIFIC DATA WAS PROVIDED. EXAMPLE 3 INITIAL RESULT WAS 1.2 COI (REACTIVE). AFTER HIGH-SPEED CENTRIFUGATION, THE RESULT WAS 1.1 COI (REACTIVE). THE RESULT FROM ANOTHER LABORATORY USING A NON-ROCHE METHOD WAS NEGATIVE. ON (B)(6) 2025, THE SAMPLE WAS REPEATED ON A COBAS PURE ANALYZER, AND THE RESULT WAS 0.94 COI (EQUIVOCAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344783 ↗
• MalfunctionJun 27, 2025False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE HIGH RESULTS FOR 15 PATIENTS' SAMPLES TESTED WITH ELECSYS TOXO IGM ASSAY ON A COBAS 6000 E601 MODULE WHEN COMPARED TO 2 DIFFERENT COMPETITORS (LIAISON AND VIDAS) AT A DIFFERENT LABORATORY. BELOW ARE THE DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES. SAMPLE 1: INITIAL RESULT: 1.34. REPEAT RESULT: NEGATIVE (TESTED ON LIAISON). SAMPLE 2 WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 1.61. REPEAT RESULT: 0.08 AND INTERPRETED AS NEGATIVE (TESTED ON VIDAS). SAMPLE 3 WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 1.85. REPEAT RESULT: 0.35 AND INTERPRETED AS NEGATIVE (TESTED ON VIDAS). THE UNITS OF MEASUREMENT WERE NOT PROVIDED. THE CUSTOMER ALLEGED THAT THE REPEAT RESULTS DID NOT CONFIRM THE INITIAL POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344596 ↗
• 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 ↗

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