Elecsys Toxo IgM 04618858190Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04015630921485), received between Apr 24, 2019 and Sep 3, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (26 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 29 reports, 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 ↗
• 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 ↗
• MalfunctionAug 28, 2024False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS TOXO IGM ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM) WHEN COPMAPRED TO A COMPETITOR'S ANALYZER (ABBOTT) AT ANOTHER FACILITY. INITIAL RESULT: 1.60 COI AND INTERPRETED AS REACTIVE. THE CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY TO BE REPEATED USING AN ABBOTT INSTRUMENT AND THE 1ST REPEAT RESULT WAS NEGATIVE. ON (B)(6) 2024 THE CUSTOMER REPEATED THE SAMPLE AND THE 2ND REPEAT RESULT WAS 1.68 COI AND INTERPRETED AS REACTIVE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT AND THE PHYSICIAN CONSIDERED THE NEGATIVE RESULT TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20090532 ↗
• MalfunctionAug 22, 2024False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT HIGH RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLE TESTED WITH ELECSYS TOXO IGM ASSAY ON A COBAS 8000 COBAS E602 IMMUNOASSAY ANALYZER WHEN COMPARED TO A COMPETITOR'S ANALYZER (ABBOTT) AT ANOTHER HOSPITAL. INITIAL RESULT: 1.96 COI AND INTERPRETED AS REACTIVE (TESTED ON E602). THE CUSTOMER SENT OUT THE SAMPLE TO ANOTHER HOSPITAL FOR RE-TESTING AS THEY HAVE INTERNAL LABORATORY PROTOCOLS IN PLACE TO CONFIRM THE REACTIVE RESULT. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2024 THE 1ST REPEAT RESULT WAS NON-REACTIVE (TESTED ON ABBOTT'S ANALYZER AT ANOTHER HOSPITAL). ON (B)(6) 2024 THE SAMPLE WAS REPEATED ON THE SAME E602 AND THE 2ND REPEAT RESULT WAS 2.03 COI AND INTERPRETED AS REACTIVE. THE 1ST REPEAT RESULT (NON-REACTIVE) WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN SUSPECTED A TOXOPLASMOSIS INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034060 ↗
• MalfunctionJul 1, 2024False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGM RESULTS FOR 1 PATIENT ON A COBAS 8000 E 602 MODULE. ON 21-MAY-2024 THE TOXO IGM RESULTS WERE 1.10 COI AND 1.10 COI (BOTH REACTIVE). THE TOXO IGM RESULT WAS 0.04 INDEX (NON-REACTIVE) WITH THE ABBOTT METHOD. THE TOXO IGG RESULT WAS 0.20 IU/ML (NON-REACTIVE) WITH THE ABBOTT METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644823 ↗
• MalfunctionApr 9, 2024False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TOXO IGM ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER WHEN COMPARED TO A NON-ROCHE (VIDAS) ANALYZER. ON (B)(6) 2024 THE SAMPLE WAS TESTED ON VIDAS, RESULTING IN A VALUE OF 0.04 AND INTERPRETED AS NEGATIVE. THE UNIT OF THIS MEASUREMENT WAS NOT PROVIDED. ON (B)(6) 2024 THE SAMPLE WAS TESTED ON E411, RESULTING IN A VALUE OF 1.15 COI AND INTERPRETED AS POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070516 ↗
• MalfunctionDec 18, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOXO IGM IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. ON 03-NOV-2023, SAMPLE 1 HAD A TOXO IGM RESULT OF 1.22 COI, INTERPRETED AS POSITIVE. ON (B)(6) 2023, THE SAMPLE WAS REPEATED ON ANOTHER UNKNOWN ANALYZER AND THE RESULT WAS 0.10 COI, INTERPRETED AS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344375 ↗
• MalfunctionDec 11, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOXO IGM (TOXO IGM) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. THE PATIENT SAMPLE WAS SENT TO TWO EXTERNAL LABORATORIES: LABORATORY 1 AND LABORATORY 2. ON (B)(6) 2023, THE INITIAL RESULT FROM THE MODULE WAS 4.81 CUT-OFF INDEX (COI) WITH AN INTERPRETATION OF "REACTIVE". ON (B)(6) 2023, THE FIRST REPEAT RESULT FROM LABORATORY 1 WAS "INDEX LESS THAN 0.10" (NON-REACTIVE). ON (B)(6) 2023, THE SECOND REPEAT RESULT FROM THE MODULE WAS 4.96 COI WITH AN INTERPRETATION OF "REACTIVE". ON (B)(6) 2023, THE THIRD REPEAT RESULT FROM LABORATORY 2 WAS "0.00 INDEX - NEGATIVE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18306433 ↗
• MalfunctionDec 1, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TOXO IGM ELECSYS RESULT FROM THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 2.0 COI (POSITIVE) AND WAS REPORTED OUTSIDE OF THE LABORATORY. AS THIS RESULT WAS NOT EXPECTED, THE SAMPLE WAS RETESTED WITH ANOTHER METHODOLOGY (ELFA) AND THE RESULT WAS NEGATIVE. TWO WEEKS LATER, ANOTHER SAMPLE WAS TESTED AND THE RESULT WAS 1.6 COI (POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252099 ↗
• MalfunctionNov 22, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOXO IGM ON A COBAS E411 RACK AND A SECOND UNKNOWN ROCHE ANALYZER. THE SAMPLE INITIALLY RESULTED IN A TOXO IGM VALUE OF 1.24 COI (REACTIVE) WHEN TESTED ON THE E411 ANALYZER ON (B)(6) 2023. THE SAMPLE WAS REPEATED ON A SECOND UNKNOWN ROCHE ANALYZER ON (B)(6) 2023, RESULTING IN A TOXO IGM VALUE OF 1.25 COI (REACTIVE). THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND TESTED USING AN UNKNOWN METHOD, RESULTING IN A TOXO IGM VALUE OF 0.07 UI/ML (NEGATIVE). THE SAMPLE WAS ALSO SENT TO A SECOND REFERENCE LABORATORY WHERE IT WAS TESTED USING AN UNKNOWN METHOD, RESULTING IN A TOXO IGM VALUE OF 0.06 INDEX (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194723 ↗
• MalfunctionNov 1, 2023False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION OF AN INCREASE IN POSITIVE RESULTS FOR ELECSYS TOXO IGM (TOXO IGM) ON A COBAS E411 RACK SYSTEM. THE CUSTOMER REPEATED 24 PATIENT SAMPLES THAT HAD POSITIVE RESULTS ON THE E411 SYSTEM BETWEEN JUL-2023 AND SEP-2023 BY A DIFFERENT METHODOLOGY AND THE RESULTS FOR 9 PATIENT SAMPLES WERE DISCREPANT. NOTE: THE SPECIFIC RESULTS WERE NOT PROVIDED. IN JUL-2023: THE RESULT FOR 1 PATIENT SAMPLE WAS POSITIVE ON THE E411 SYSTEM. THE RESULT FROM A DIFFERENT METHODOLOGY WAS NEGATIVE. IN AUG-2023: THE RESULTS FOR 2 PATIENT SAMPLES WERE POSITIVE ON THE E411 SYSTEM. THE RESULTS FOR BOTH PATIENT SAMPLES FROM A DIFFERENT METHODOLOGY WERE NEGATIVE. IN SEP-2023: THE RESULTS FOR 6 PATIENT SAMPLES WERE POSITIVE ON THE E411 SYSTEM. THE RESULTS FOR THE 6 PATIENT SAMPLES FROM A DIFFERENT METHODOLOGY WERE NEGATIVE. FOR ALL PATIENT SAMPLES, THE NEGATIVE RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049951 ↗
• MalfunctionOct 25, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS TOXO IGM (TOXO IGM) ON A COBAS E 411 ANALYZER (RACK SYSTEM). PATIENT 1: ON (B)(6) 2023, THE TOXO IGM RESULT WAS 0.832 COI (BORDERLINE). ON (B)(6) 2023, THE TOXO IGM RESULT WAS 0.891 COI (BORDERLINE). ON (B)(6) 2023, THE CHEMILUMINESCENT IMMUNOASSAY (CLIA) METHOD TOXO IGM RESULT WAS 4.3 UA/ML (NEGATIVE). PATIENT 2: ON (B)(6) 2023, THE TOXO IGM RESULT WAS 0.956 COI (BORDERLINE). ON (B)(6) 2023, THE TOXO IGM RESULT WAS 1.02 COI (POSITIVE). ON (B)(6) 2023, THE TOXO IGM RESULT WAS 1.02 COI (POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18006848 ↗
• MalfunctionAug 10, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOXO IGM (TOXO IGM) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 RACK. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLE WAS SENT OUT AND WAS ANALYZED USING THE CHEMILUMINESCENT IMMUNOASSAY (CLIA) LABORATORY METHOD. THE REPEAT RESULT WAS ON (B)(6) 2023, THE INITIAL RESULT FROM THE ANALYZER WAS "NON-REACTIVE" WITH A CUT-OFF INDEX (COI) OF 0.256. ON (B)(6) 2023, THE FIRST REPEAT RESULT FROM THE ANALYZER WAS "REACTIVE" WITH A COI OF 1.53. ON (B)(6) 2023, THE SECOND REPEAT RESULT FROM THE ANALYZER WAS "REACTIVE" WITH A COI OF 1.51. ON (B)(6) 2023, THE THIRD REPEAT RESULT FROM THE CLIA METHOD WAS "NON-REACTIVE" WITH A COI OF 0.08.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503050 ↗
• MalfunctionAug 10, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOXO IGM (TOXO IGM) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 RACK. THE INITIAL RESULT WAS REPORTED TO THE PATIENT. THE PATIENT REQUESTED CONFIRMATION OF THE RESULT AND A NEW SAMPLE WAS COLLECTED. THE NEW PATIENT SAMPLE WAS ALSO SENT OUT TO A REFERENCE LABORATORY FOR CONFIRMATION AND WAS ANALYZED USING THE MICROPARTICLE CHEMILUMINESCENCE LABORATORY METHOD. ON (B)(6) 2023: THE INITIAL RESULT OF THE INITIAL SAMPLE IN THE PRIMARY TUBE FROM THE ANALYZER WAS "REACTIVE" WITH A CUT-OFF INDEX (COI) OF 1.4. ON (B)(6) 2023: THE REPEAT RESULT OF THE NEW SAMPLE IN A SECONDARY TUBE FROM THE ANALYZER WAS "REACTIVE" WITH A COI OF 1.21. ON (B)(6) 2023: THE REPEAT RESULT OF THE ALIQUOTED NEW SAMPLE FROM THE REFERENCE LABORATORY WAS "NON-REACTIVE" WITH A COI OF 0.08. ON (B)(6) 2023: THE REPEAT RESULT OF THE INITIAL SAMPLE IN A SAMPLE CUP FROM THE ANALYZER WAS "REACTIVE" WITH A COI OF 1.38. THE REPEAT RESULT OF THE NEW SAMPLE IN A SAMPLE CUP FROM THE ANALYZER WAS "REACTIVE" WITH A COI OF 1.18.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502966 ↗
• MalfunctionMay 19, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF A FALSE POSITIVE TOXO IGM ELECSYS RESULT FROM COBAS 6000 E601 MODULE SERIAL NUMBER (B)(6). THE RESULTS WERE 1.03 COI AND 1.04 COI (REACTIVE). THE CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY USING CLIA METHODOLOGY AND THE RESULT WAS NEGATIVE AND DEEMED CORRECT. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962095 ↗
• MalfunctionApr 25, 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 - COBAS E 602 MODULE WITH SERIAL NUMBER: (B)(6). THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER WAS NOT ABLE TO PROVIDE ANY PATIENT RESULTS BUT STATED THAT THEY HAVE OBSERVED A HIGHER FREQUENCY OF BORDERLINE/REACTIVE TOXO IGM RESULTS SINCE USING THE REPORTED REAGENT LOT NUMBER. THE REPORTER FURTHER STATED THAT BEFORE USING THE REPORTED REAGENT LOT NUMBER, THEY WOULD ONLY SEND 0.44% OF INITIALLY POSITIVE PATIENT SAMPLES FOR CONFIRMATION. THIS NUMBER INCREASED TO 1.16% SINCE USING THE REPORTED REAGENT LOT NUMBER (INCLUDING POTENTIALLY TRUE POSITIVE PATIENT SAMPLES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809431 ↗
• MalfunctionApr 18, 2023False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT REACTIVE RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS TOXO IGM ASSAY ON A COBAS 6000 E601 MODULE SERIAL NUMBER (B)(4) WHEN SAMPLE 1 WAS COMPARED TO ELECSYS TOXO IGM REAGENT WITH A DIFFERENT LOT NUMBER AND SAMPLE 2 WAS COMPARED TO A NON-ROCHE ANALYZER. THE FOLLOWING RESULTS WERE OBTAINED: SAMPLE 1: INITIAL RESULT: NON-REACTIVE (0.283 COI) (TEST PERFORMED (B)(6) 2023 WITH LOT NUMBER 658248. THIS RESULT IS CONSIDERED CORRECT.). REPEAT RESULT: WAS REACTIVE (1.08 COI) (TESTED WITH LOT NUMBER 671949 AND CONSIDERED INCORRECT). SAMPLE 2: INITIAL RESULT: REACTIVE (1.09 COI) (TESTED WITH LOT NUMBER 671949 AND CONSIDERED INCORRECT) REPEAT RESULT: NON-REACTIVE (< 3.0 AU/ML) (TESTED ON A DIASORIN ANALYZER). NO ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE ELECSYS TOXO IGM REAGENT LOT NUMBER IN QUESTION WAS WITH AN EXPIRATION DATE OF OCT-2023. THE ELECSYS TOXO IGM REAGENT LOT NUMBER USED FOR THE INITIAL RESULT OF SAMPLE 1 (NON-REACTIVE) WAS 658248. THE EXPIRATION DATE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765128 ↗
• MalfunctionApr 10, 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 6000 E601 MODULE SERIAL NUMBER (B)(4). THE CUSTOMER STATED THEY HAVE BEEN RECEIVING A HIGHER NUMBER OF FALSE POSITIVE PATIENT RESULTS WITH REAGENT LOT 671949. NO SPECIFIC PATIENT DATA WAS PROVIDED. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708394 ↗
• MalfunctionMar 13, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE REACTIVE ELECSYS TOXO IGM IMMUNOASSAY RESULTS FOR 1 PATIENT ON A COBAS E 602 MODULE COMPARED TO A COBAS 6000 SYSTEM AND A MINIVIDAS ANALYZER. ON (B)(6) 2022, THE E602 TOXO IGM RESULT WAS 1.62 COI, INTERPRETED AS REACTIVE. ON (B)(6) 2022, THE PATIENT WAS SENT TO ANOTHER LABORATORY. A NEW SAMPLE WAS COLLECTED AND RUN ON A COBAS 6000 ANALYZER AND A MINIVIDAS ANALYZER. THE COBAS 6000 TOXO IGM RESULT WAS 1.53 COI, INTERPRETED AS REACTIVE. THE MINIVIDAS TOXO IGM RESULT WAS 0.05 COI, INTERPRETED AS NON-REACTIVE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E602 ANALYZER SERIAL NUMBER IS (B)(4). THE COBAS 6000 SYSTEM SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531531 ↗
• MalfunctionFeb 22, 2023False Negative Result; False Negative Result

  THE INITIAL REPORTER QUESTIONED NEGATIVE RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS TOXO IGM (TOXO IGM) ON A COBAS 6000 E 601 MODULE COMPARED TO 2 OTHER METHODS. PATIENT 1 RESULT FROM THE E601 MODULE WAS 0.335 COI (NEGATIVE). THE RESULT FROM THE SIEMENS METHOD WAS 1.260 COI (POSITIVE). THE RESULT FROM CERBA FRANCE LABORATORY WAS 8.3 COI (POSITIVE). PATIENT 2 RESULT FROM THE E601 MODULE WAS 0.339 COI (NEGATIVE). THE RESULT FROM THE SIEMENS METHOD WAS 2.1 COI (POSITIVE). THE RESULT FROM CERBA FRANCE LABORATORY WAS 10.4 COI (POSITIVE). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E601 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416128 ↗
• MalfunctionJun 23, 2022False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH THE ELECSYS TOXO IGM IMMUNOASSAY ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE FIRST SAMPLE RESULTED IN A TOXO IGM VALUE OF 4.30 COI (REACTIVE) WHEN TESTED ON THE E411 ANALYZER. THE 4.30 COI (REACTIVE) VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING WITH AN UNKNOWN TOXO IGM METHOD, RESULTING IN A NEGATIVE RESULT. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND RESULTED IN A TOXO IGM VALUE OF 4.28 COI (REACTIVE) WHEN TESTED ON THE E411 ANALYZER. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING WITH AN UNKNOWN TOXO IGM METHOD, RESULTING IN A NEGATIVE RESULT. THE SERIAL NUMBER OF THE E411 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14790901 ↗
• MalfunctionJun 17, 2022False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TOXO IGM IMMUNOASSAY ON A COBAS 6000 E 601 MODULE (SERIAL NUMBER (B)(4). NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A TOXO IGM VALUE OF 2.55 COI (REACTIVE) WHEN TESTED ON THE E 601 ANALYZER. THE SAMPLE WAS REPEATED USING THE BIOMERIUEX METHOD AND THE RESULT WAS NEGATIVE. THE SAMPLE WAS REPEATED ON THE E 601 ANALYZER ON (B)(6) 2022, RESULTING IN ONLY A DATA FLAG INDICATING SYSTEM REAGENT VOLUME WAS SHORT. THE SAMPLE WAS REPEATED AGAIN ON THE E 601 ANALYZER ON (B)(6) 2022, RESULTING IN A VALUE OF 2.52 COI (REACTIVE). ON (B)(6) 2022, THE SAMPLE WAS TESTED WITH AN UNKNOWN COMPETITOR CHEMILUMINESCENCE ASSAY, RESULTING IN A NEGATIVE TOXO IGM VALUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14735009 ↗
• MalfunctionMay 26, 2022False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOXO IGM RESULTS FOR ONE PATIENT TESTED ON A COBAS 6000 E 601 MODULE SERIAL NUMBER 32L6-09. ON (B)(6) 2022, THE PATIENT'S INITIAL ELECSYS TOXO IGM RESULT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2022, THE PATIENT WENT TO A REFERENCE CENTER FOR FURTHER TESTING. ON (B)(6) 2022, THE PATIENT HAD A NEW SAMPLE COLLECTED AND THE CUSTOMER PERFORMED TESTING WITH THE E 601 MODULE. ON (B)(6) 2022, THE PATIENT'S INITIAL ELECSYS TOXO IGM RESULT WAS POSITIVE. THE SPECIFIC VALUE WAS REQUESTED BUT NOT PROVIDED. ON (B)(6) 2022, THE PATIENT'S TOXO IGM RESULT AT THE REFERENCE CENTER AND BY "CMIA" METHODOLOGY WAS NEGATIVE. ON (B)(6) 2022, THE PATIENT'S ELECSYS TOXO IGM RESULT WAS 5.7 COI POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516872 ↗