Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation 20764957322Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630913862), received between Jul 21, 2021 and Dec 8, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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.

• MalfunctionDec 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ALT) RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 4000 C311 STAND ALONE SYSTEM AND A COBAS PURE ANALYZER. ON 21-OCT-2025, SAMPLE 1 HAD AN INITIAL ALT RESULT OF 52 IU/L FROM THE COBAS PURE ANALYZER. THE SAMPLE WAS ALSO TESTED ON A C 311 ANALYZER AND THE RESULT WAS 24 IU/L. THE EXACT DATE OF TESTING ON THE C 311 ANALYZER WAS NOT PROVIDED. SAMPLE 2 HAD AN INITIAL ALT RESULT OF 51.2 IU/L FROM THE COBAS PURE ANALYZER. THE SAMPLE WAS ALSO TESTED ON A C 311 ANALYZER AND THE RESULT WAS 21.8 IU/L. THE EXACT DATES OF TESTING WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744730 ↗
• MalfunctionMay 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION RESULT FROM THE COBAS 6000 C501 MODULE, SUSPECTING A NEGATIVE INTERFERENCE. THE INITIAL RESULT WAS 67.3 U/L, ACCOMPANIED BY A DATA FLAG, WITH A REPEAT RESULT OF 97.6 U/L, ALSO ACCOMPANIED BY A DATA FLAG. AFTER THE SAMPLE WAS DILUTED, THE DATA FLAG DID NOT OCCUR, HOWEVER, THIS RESULT WAS NOT REPRODUCIBLE ON REPEAT TESTING ON DIFFERENT ANALYZERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116026 ↗
• MalfunctionJan 23, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ASTL AND ALTL ON AN INTEGRA 400 PLUS SYSTEM. THE CUSTOMER NOTED THAT THE PATIENT SAMPLE WAS ICTERIC. THIS MEDWATCH WILL APPLY TO THE ALT ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT-0066446 FOR INFORMATION RELATED TO THE AST ASSAY. THE SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 77 U/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED TWICE, RESULTING IN AST VALUES OF 279 U/L WITH A DATA FLAG AND 715 U/L WITH A DATA FLAG. THE SAMPLE WAS PLACED IN A CUP AND REPEATED TWICE, RESULTING IN AST VALUES OF 731 U/L WITH A DATA FLAG AND 732 U/L WITH A DATA FLAG. THE SAMPLE INITIALLY RESULTED IN AN ALT VALUE OF 36 U/L WITH A DATA FLAG AND IT REPEATED AS 1027 U/L WITH A DATA FLAG. THE SAMPLE WAS PLACED IN A CUP AND REPEATED TWICE, RESULTING IN ALT VALUES OF 1044 U/L WITH A DATA FLAG AND 1063 U/L WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18564149 ↗
• MalfunctionFeb 8, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ALTL ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ALTL) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS REPORTED TO THE EMERGENCY DEPARTMENT WHICH REQUESTED VERIFICATION. A RERUN WAS PERFORMED ON THE REPORTED MODULE AND THEIR OTHER C 501 MODULE. THE INITIAL RESULT FROM THE MODULE WAS 363.9 U/L. THE FIRST REPEAT RESULT FROM THE MODULE WAS 17.8 U/L. THE SECOND REPEAT RESULT FROM THE OTHER MODULE WAS 18.1 U/L. THE REPEAT RESULT FROM THE OTHER MODULE CONFIRMED THE RESULT. THE REAGENT LOT NUMBER IS 67320501. THE EXPIRATION DATE IS 31-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16327237 ↗
• MalfunctionJan 14, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ALTL ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION RESULT FOR ONE PATIENT SAMPLE WITH A COBAS 8000 C702 MODULE. THE REPORTER STATED THEY WERE HAVING ISSUES OBTAINING VALID VALUES DUE TO FLAGGING ON THIS SPECIFIC PATIENT SAMPLE AND SUSPECTED AN INTERFERENCE. THE REPORTER PROVIDED THE FOLLOWING RESULTS WITHOUT ANY FLAGGING: THE INITIAL RESULT WAS 18 U/L. THE REPEATED RESULT WAS 28.5 U/L. THE SECOND REPEATED RESULT WAS 28.4 U/L. IT IS UNKNOWN IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13259429 ↗
• MalfunctionJul 21, 2021Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ALTL ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ALTL) ON A COBAS 4000 C (311) STAND ALONE SYSTEM COMPARED TO THE SIEMENS DIMENSION RXL MAX METHOD. "PATIENT 2" INITIAL RESULT FROM THE C311 SYSTEM WAS 6.1 U/L. THE RESULT FROM THE SIEMENS METHOD WAS 22 U/L. ON (B)(6) 2021 "PATIENT 3" INITIAL RESULT FROM THE C311 SYSTEM WAS 20.1 U/L. THE RESULT FROM THE SIEMENS METHOD WAS 32 U/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE C311 ANALYZER SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206198 ↗