Elecsys Myoglobin 07027583190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630940059), received between Dec 6, 2022 and Nov 19, 2025 — 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.

• MalfunctionNov 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS MYOGLOBIN ON A COBAS E 801 ANALYTICAL UNIT. TWO SERUM TUBES WERE COLLECTED FROM THE PATIENT AT THE SAME TIME. THE FIRST SERUM TUBE RESULTED IN A MYOGLOBIN VALUE OF 28.5 NG/ML THE SECOND TUBE RESULTED IN A VALUE OF 388 NG/ML. AN EDTA PLASMA TUBE COLLECTED AT THE SAME TIME RESULTED IN A MYOGLOBIN VALUE OF 159 NG/ML. ALL TUBES WERE REPEATED AND ALL RECOVERED THE SAME VALUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597482 ↗
• MalfunctionMay 13, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS MYOGLOBIN (MYO) RESULTS FROM FIVE PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS: PATIENT SAMPLE 1: THE INITIAL RESULT FROM THE ANALYZER WAS <21 NG/ML. THE REPEAT RESULT FROM A COBAS E 411 ANALYZER WAS 256.7 NG/ML. PATIENT SAMPLE 2: THE INITIAL RESULT FROM THE ANALYZER WAS <21 NG/ML. THE REPEAT RESULT FROM A COBAS E 411 ANALYZER WAS 131.6 NG/ML. PATIENT SAMPLE 3: THE INITIAL RESULT FROM THE ANALYZER WAS <21 NG/ML. THE REPEAT RESULT FROM A COBAS E 411 ANALYZER WAS 148.6 NG/ML. PATIENT SAMPLE 4: THE INITIAL RESULT FROM THE ANALYZER WAS <21 NG/ML. THE REPEAT RESULT FROM A COBAS E 411 ANALYZER WAS 281.7 NG/ML. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY, AS THE RESULTS DID NOT MATCH THE PATIENTS' CLINICAL DIAGNOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009295 ↗
• MalfunctionJan 30, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 3 PATIENT SAMPLES TESTED FOR ELECSYS MYOGLOBIN (MYO) ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 21.0 NG/ML WITH A DATA FLAG. THE REPEAT RESULT FROM AN E411 ANALYZER WAS 76.68 NG/ML. PATIENT 2 INITIAL RESULT WAS 21.0 NG/ML WITH A DATA FLAG. THE REPEAT RESULT FROM AN E411 ANALYZER WAS 53.72 NG/ML. PATIENT 3 INITIAL RESULT WAS 21.0 NG/ML WITH A DATA FLAG. THE REPEAT RESULT FROM AN E411 ANALYZER WAS 1260 NG/ML. THE REPEAT RESULT FROM THE E801 ANALYZER WAS 1168 NG/ML. THE INITIAL RESULTS DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL CONDITION. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275602 ↗
• MalfunctionJul 10, 2024False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS MYOGLOBIN (MYO) RESULTS FROM FIVE PATIENT SAMPLES (THREE FROM THE SAME PATIENT) TESTED ON THE COBAS E 801 ANALYTICAL UNIT AND THE COBAS C 503 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS MYOGLOBIN (MYO) ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM ASSAY. PATIENT SAMPLE 1A ON (B)(6) 2024: THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE ANALYZER WAS <21 UG/L. THIS RESULT DID NOT CORRESPOND WITH THE CK RESULT OF 53.9 UKAT/L WITH A DATA FLAG (UNDILUTED) AND 55.9 UKAT/L (WITH DILUTION) PROMPTING THE DILUTION OF THE PATIENT SAMPLE. THE FIRST REPEAT RESULT AT 10X DILUTION FROM THE ANALYZER WAS 210 UG/L WITH A DATA FLAG. THE SECOND REPEAT RESULT AT 20X DILUTION FROM THE ANALYZER WAS 420 UG/L WITH A DATA FLAG. THE THIRD REPEAT RESULT AT 100X DILUTION FROM THE ANALYZER WAS 2393 UG/L. THE REPEAT RESULT AT 900X DILUTION FROM THE ANALYZER WAS > 20,000 UG/L THE RESULT FROM THE OTHER LABORATORY THAT USES THE CHEMILUMINESCENCE IMMUNOASSAY (CLIA) METHOD WAS 59.7 NG/ML. THIS RESULT CORRESPONDS WITH THE PATIENT¿S CK-MB RESULT. THE REPEAT RESULT FROM THE COBAS C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715176 ↗
• MalfunctionApr 11, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 3 PATIENT SAMPLES TESTED FOR ELECSYS MYOGLOBIN (MYO) ON A COBAS E 801 ANALYTICAL UNIT. FOR ALL 3 PATIENT SAMPLES, THE INITIAL RESULT WAS < 21.0 NG/ML WITH A DATA FLAG. PATIENT 1 REPEAT RESULT WAS 66.4 NG/ML. PATIENT 2 REPEAT RESULT WAS 350 NG/ML. "PATIENT 5" REPEAT RESULT WAS 281 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089425 ↗
• MalfunctionDec 6, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TROPONIN T HS ON A COBAS E 801 MODULE (SERIAL NUMBER (B)(4)). THE TROPONIN T HS RESULTS DID NOT AGREE WITH THE CLINICAL EXAMINATION AND HISTORY OF THE PATIENT AND THE CUSTOMER SUSPECTS AN INTERFERENCE-BASED DISCREPANT HIGH ELECYS TROPONIN T HS RESULT. THE PATIENT SAMPLE ALSO GENERATED QUESTIONABLE ELECSYS MYOGLOBIN RESULTS, WHICH WERE NOT TAKEN INTO CONSIDERATION SINCE THE ELECSYS TROPONIN T VALUES WERE ALREADY CONSIDERED IMPLAUSIBLE. THIS MEDWATCH WILL APPLY TO THE ELECSYS MYOGLOBIN ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS TROPONIN T HS ASSAY. THE SAMPLE INITIALLY RESULTED IN A MYOGLOBIN VALUE OF 53.1 NG/ML. THE SAMPLE WAS DILUTED 10 TIMES AND REPEATED, RESULTING IN A VALUE OF <210 NG/ML, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS THEN REPEATED UNDILUTED, RESULTING IN A VALUE OF 21.0 NG/ML, ACCOMPANIED BY A DATA FLAG. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923282 ↗