Elecsys AntiTg Assay 6368697190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630929726), received between Jul 19, 2021 and Oct 20, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS ANTI-TG (ANTI-TG) ON A COBAS E 601 MODULE. THE FIRST RESULT WITH A 1:10 DILUTION WAS 34.74 IU/ML. THE SECOND RESULT WAS >4000 IU/ML WITH A DATA FLAG. THE THIRD RESULT WITH A 1:10 DILUTION WAS 99.97 IU/ML. THE SAMPLE WAS TESTED BY A CHEMILUMINESCENT IMMUNOASSAY METHOD AND THE RESULT WAS 312.000 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17976564 ↗
• MalfunctionSep 1, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR 2 PATIENTS TESTED FOR ELECSYS ANTI-TG (ANTI-TG) ON A COBAS E 411 IMMUNOASSAY ANALYZER. ON (B)(6) 2023 PATIENT 1 INITIAL RESULT FROM THE E411 ANALYZER WAS 98.7 IU/ML OR 96.7 IU/ML. ON (B)(6) 2023 THE PATIENT WAS TESTED AT A DIFFERENT LABORATORY USING AN ABBOTT ALINITY INSTRUMENT AND THE RESULT WAS 2490.79 IU/ML. ON (B)(6) 2023 THE PATIENT COMPLAINED ABOUT THE INITIAL RESULT RECEIVED FROM THE E411 ANALYZER. THE ORIGINAL SAMPLE WAS REPEATED ON THE E411 ANALYZER WITH A RESULT OF 92.11 IU/ML. ON (B)(6) 2023 THE ORIGINAL SAMPLE WAS SENT TO THE LABORATORY USING THE ABBOTT ALINITY INSTRUMENT AND THE REPEAT RESULT WAS 2791.79 IU/ML OR 2791.03 IU/ML. ON (B)(6) 2023 A NEW SAMPLE WAS OBTAINED AND TESTED ON THE E411 ANALYZER WITH A RESULT OF 79.4 IU/ML. THE SAMPLE FROM (B)(6) 2023 WAS SENT TO 2 OTHER LABORATORIES WHERE THE RESULT FROM A COBAS 6000 SYSTEM WAS 71.5 IU/ML AND THE RESULT FROM THE MINDRAY METHOD WAS 670.32 IU/ML. THE PATIENT EXPECTED THE ANTI-TG RESULT TO BE HIGH AS THE PREVIOUS RESULT FROM (B)(6) 2022 ON AN ARCHITECT I2000 INSTRUMENT WAS 2935.57 IU/ML. ON AN UNKNOWN DATE, PATIENT 2 INITIAL RESULT FROM THE E411 ANALYZER WAS 78.4 IU/M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671005 ↗
• MalfunctionJul 19, 2022Low Test Results; Manufacturing, Packaging or Shipping Problem; Low Test Results; Manufacturing, Packaging or Shipping Problem

  THE INITIAL REPORTER CHANGED TO REAGENT LOT 574764 (NEW LOT) AND QUESTIONED LOW RESULTS FOR 5 PATIENT SAMPLES TESTED BETWEEN THE NEW REAGENT LOT AND REAGENT LOT 595368 (OLD LOT) FOR ELECSYS ANTI-TG (ANTI-TG) ON A COBAS 8000 E 602 MODULE. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 3 PATIENT SAMPLES: PATIENT 1 RESULT FROM THE NEW LOT WAS 39.25 IU/ML. THE RESULT FROM THE OLD LOT WAS 292.4 IU/ML. PATIENT 2 RESULT FROM THE NEW LOT WAS 57.13 IU/ML. THE RESULT FROM THE OLD LOT WAS 143.7 IU/ML. PATIENT 3 RESULT FROM THE NEW LOT WAS 159.6 IU/ML. THE RESULT FROM THE OLD LOT WAS 1247 IU/ML. QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E602 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15054434 ↗
• MalfunctionJul 12, 2022High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-TG (ANTI-TG) ON TWO COBAS 6000 E 601 MODULES COMPARED TO AN UNSPECIFIED METHOD FROM ANOTHER HOSPITAL. ON (B)(6) 2022 THE RESULT FROM THE E601 MODULE WAS 510.600 IU/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022 THE PATIENT WENT TO ANOTHER HOSPITAL TO CHECK THE RESULT. THE RESULT AT THE OTHER HOSPITAL WAS 60.02 IU/ML. ON (B)(6) 2022 THE CUSTOMER SENT THE ORIGINAL SAMPLE TO ANOTHER HOSPITAL AND THE RESULT WAS 58.50 IU/ML. ON (B)(6) 2022 THE SAMPLE WAS REPEATED ON THE E601 MODULE IN QUESTION AND THE RESULT WAS 583.6 IU/ML. THE CUSTOMER RAN THE SAMPLE ON ANOTHER E601 MODULE AND THE RESULT WAS 552.1 IU/ML. THE SERIAL NUMBER FOR ONE E601 MODULE WAS 26E4-23. THE SERIAL NUMBER FOR THE OTHER E601 MODULE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14984798 ↗
• MalfunctionSep 8, 2021High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH ROCHE DIAGNOSTICS ELECSYS ANTI-TG ON UNKNOWN ROCHE ELECSYS ANALYZERS. THE CUSTOMER SUSPECTED THE SAMPLES CONTAINED AN INTERFERENT TO A COMPONENT OF THE ANTI-TG ASSAY. NO UNITS OF MEASURE WERE PROVIDED. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2021, THE FIRST SAMPLE FROM THE PATIENT WAS TESTED ON THE CUSTOMER'S UNKNOWN ROCHE ELECSYS ANALYZER, RESULTING IN AN ANTI-TG VALUE OF 40. ON (B)(6) 2021, A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AT A SECOND SITE AND TESTED USING A SECOND UNKNOWN ROCHE ELECSYS ANALYZER AND THE ANTI-TG RESULT WAS 13. THIS SAMPLE WAS ALSO REPEATED AT A THIRD SITE ON A THIRD UNKNOWN ROCHE ELECSYS ANALYZER, RESULTING IN AN ANTI-TG VALUE THAT WAS CONSISTENT WITH THE INITIAL VALUE OF 13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439074 ↗
• MalfunctionJul 19, 2021Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ANTI-TG ELECSYS RESULTS FROM COBAS 8000 - COBAS E 602 MODULE SERIAL NUMBER (B)(4) FOR A PATIENT WITH THYROID CARCINOMA. INTERFERENCE WITH THE ASSAY WAS SUSPECTED. THE PATIENT IS BEING MONITORED AFTER A THYROIDECTOMY (SURGICAL REMOVAL OF THE THYROID GLAND DUE TO CARCINOMA). IF TG REMAINS PRESENT OR RISES, THIS WOULD BE AN INDICATION OF A RESIDUAL TUMOR. THE ANTI-TG RESULTS FROM THE COBAS ANALYZER WERE NORMAL. HOWEVER, THE RESULTS WERE VERY STRONGLY POSITIVE ON A VIDAS ANALYZER AND ON A PHADIA IMMUNOCAP SYSTEM. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189308 ↗