Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation 08056773190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613336120989), received between Dec 12, 2022 and Jan 10, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ASPARTATE AMINOTRANSFERASE (AST) AND ALANINE AMINOTRANSFERASE (ALT) RESULTS FOR ONE PATIENT FROM THE COBAS PURE C 303 ANALYTICAL UNIT. THE CUSTOMER ALLEGED SOMETHING WITH THE PATIENT SAMPLE CAUSED DIFFERENT RESULTS FOR THE ASSAYS WITH PYRIDOXAL PHOSPHATE ACTIVATION COMPARED TO THE ASSAYS WITHOUT AS WERE USED ON THE COBAS C311. THIS MEDWATCH WILL COVER ALT. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE AST ASSAY. FOR ALT: THE INITIAL RESULTS WERE 44.1 U/L AND 42.3 U/L. THE REPEAT RESULTS USING COBAS C311 ANALYZERS WERE 15 U/L, 19.4 U/L, AND 19 U/L. THE RESULTS FROM THE COBAS C311 WERE BELIEVED CORRECT AND REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21127329 ↗
• MalfunctionDec 26, 2024Device Difficult to Setup or Prepare; Low Test Results; Device Difficult to Setup or Prepare; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT ALTP RESULTS FOR 5 PATIENTS' SERUM SAMPLES NOT MATCHING THE ALTP RESULTS IN HEPARINIZED PLASMA SAMPLES TESTED ON A COBAS PURE C303 ANALYTICAL UNIT. SAMPLE 1 (PATIENT 1): SERUM RESULT: 72.2 U/L. PLASMA RESULT: 66.1 U/L. SAMPLE 2 (PATIENT 2): SERUM RESULT: 21.1 U/L. PLASMA RESULT: 15.6 U/L. SAMPLE 3 (PATIENT 3): SERUM RESULT: 91.2 U/L. PLASMA RESULT: 86.8 U/L. SAMPLE 4 (PATIENT 4): SERUM RESULT: 25.3 U/L. PLASMA RESULT: 19.3 U/L. THE CUSTOMER WAS PLANNING TO SWITCH FROM PERFORMING TESTS IN SERUM TUBES TO HEPARIN TUBES AND THIS WAS WHAT PROMPTED THE REPEAT OF THE SAMPLES. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SERUM RESULTS WERE CONSIDERED TO BE CORRECT. ON (B)(6) 2024: SAMPLE 5 (PATIENT 5): SERUM RESULT: 25.5 U/L. PLASMA RESULT: 17.6 U/L. THE CUSTOMER SUSPECTED POTENTIAL INTERFERENCE BETWEEN THE ANTICOAGULANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018745 ↗
• MalfunctionMay 17, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALTLP ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION RESULTS FOR 3 SAMPLES FROM THE SAMPLE PATIENT ON A COBAS C 503 ANALYTICAL UNIT. ON (B)(6) 2024, SAMPLE 1 HAD AN INITIAL ALTP RESULT OF 318 U/L. A 1:50 DILUTION WAS PERFORMED ON THE SAMPLE AND THE RESULT WAS 733 U/L. ON (B)(6) 2024, SAMPLE 2 HAD AN INITIAL ALTP RESULT WAS 793 U/L. CLARIFICATION ON WHETHER THIS RESULT WAS OBTAINED FROM A 1:10 DILUTION OF THE SAMPLE WAS REQUESTED BUT NOT PROVIDED. A 1:50 DILUTION WAS PERFORMED ON THE SAMPLE AND THE RESULT WAS 1229 U/L. ON (B)(6) 2024, SAMPLE 3 HAD AN INITIAL ALTP RESULT WAS 477 U/L. A 1:50 DILUTION WAS PERFORMED ON THE SAMPLE AND THE RESULT WAS 996 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341959 ↗
• MalfunctionApr 30, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL AST RESULT WAS 988 U/L WITH A DATA FLAG. THE REPEAT RESULT WITH A DILUTION WAS 523 U/L WITH A DATA FLAG. THE RESULT FROM ANOTHER ANALYZER WAS 906 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212730 ↗
• MalfunctionApr 30, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL ALT RESULT WAS 2634 U/L WITH A DATA FLAG. THE REPEAT RESULT WITH A DILUTION WAS 1333 U/L WITH A DATA FLAG. THE REPEAT RESULT FROM A NON-ROCHE ANALYZER WAS 410 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212594 ↗
• MalfunctionApr 2, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALANINE AMINOTRANSFERASE ACC. TO IFCC W/ PYRIDOXAL PHOSPHATE ACTIVATION RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 303 ANALYTICAL UNIT. THE SERUM RESULT WAS 21.8 U/L AND THE LI HEPARIN RESULT WAS 13 U/L. THE LI-HEPARIN RESULT WAS REPORTED OUTSIDE OF THE LABORATORY BECAUSE THIS RESULT CORRESPONDED TO THE PATIENT'S CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018962 ↗
• MalfunctionFeb 28, 2024Unable to Obtain Readings; Unable to Obtain Readings

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT'S SERUM/PLASMA SAMPLE TESTED WITH ALANINE AMINOTRANSFERASE (ALTP) ASSAY ON A COBAS PURE C303 ANALYTICAL UNIT. THE SAMPLE WAS TESTED IN 3 TUBES. THE BELOW RESULTS WERE OBTAINED WHEN USING TWO DIFFERENT LITHIUM HEPARIN TUBES: INITIAL RESULT: -1.70 U/L (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS THEN REPEATED. THE FOLLOWING REPEAT RESULTS WERE OBTAINED AND THEY WERE ALL ACCOMPANIED BY A DATA FLAG: 1.47 U/L. 0.683 U/L. 2.77 U/L. 4.10 U/L. THE RESULT OF -1.41 U/L (ACCOMPANIED BY A DATA FLAG) WAS OBTAINED WHEN THE K2 EDTA TUBE WAS USED. THE CUSTOMER SUSPECTED AN INTERFERENCE SINCE THE OBTAINED MEASUREMENTS WERE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18802655 ↗
• MalfunctionJun 5, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION (ALTP) ON A COBAS PURE C 303 ANALYTICAL UNIT COMPARED TO A COBAS 8000 SYSTEM. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 4 PATIENT SAMPLES. ON (B)(6) 2023 PATIENT 1 RESULT FROM THE C303 UNIT WAS 12 U/L. THE RESULT FROM THE COBAS 8000 SYSTEM WAS 24 U/L. ON (B)(6) 2023 PATIENT 2 RESULT FROM THE C303 UNIT WAS 21 U/L. THE RESULT FROM THE COBAS 8000 SYSTEM WAS 38 U/L. ON (B)(6) 2023 PATIENT 3 RESULT FROM THE C303 UNIT WAS 14 U/L. THE RESULT FROM THE COBAS 8000 SYSTEM WAS 24 U/L. ON (B)(6) 2023 PATIENT 4 RESULT FROM THE C303 UNIT WAS 12 U/L. THE RESULT FROM THE COBAS 8000 SYSTEM WAS 23 U/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS FROM THE COBAS 8000 SYSTEM WERE BELIEVED TO BE CORRECT. THE ALTP REAGENT LOT NUMBER WAS 70466801 WITH AN EXPIRATION DATE OF 31-MAY-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064739 ↗
• MalfunctionJan 11, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALTLP ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. ON (B)(6) 2022, THE FIRST SAMPLE'S INITIAL ALTLP RESULT WAS 272 U/L. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. A 1:2 DILUTION WAS MADE FROM THE SAMPLE AND THE RESULT WAS 582 U/L. ON (B)(6) 2022, A THIRD 1:2 DILUTION WAS MADE FROM THE FIRST SAMPLE. THE ALTLP RESULT WAS 1150 U/L. A 1:5 DILUTION WAS MADE FROM THE FIRST SAMPLE AND THE RESULT WAS 970 U/L. A 1:10 DILUTION WAS MADE FROM THE FIRST SAMPLE AND THE RESULT WAS 842 U/L. A SECOND SAMPLE WAS COLLECTED. THE ALTP RESULT WAS 508 U/L. A 1:2 DILUTION WAS MADE USING THE SECOND SAMPLE AND THE ALTLP RESULT WAS 852 U/L. ON (B)(6) 2022, THE FIRST SAMPLE WAS TESTED AGAIN AND THE RESULT WAS 921 U/L. THE REAGENT LOT NUMBER IS 66105201. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141306 ↗
• MalfunctionDec 12, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY PERFORMED MAINTENANCE ON THE COBAS PRO C 503 ON 22-NOV-12022 AND CONTROLS RUN FOR ALTLP ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION PASSED AFTER THE MAINTENANCE. CONTROLS STARTED RECOVERING ERRATICALLY AND FAILED ON 25-NOV-2022. THE OPERATOR CALIBRATED THE ALT REAGENT PACK AND CONTROLS WERE ACCEPTABLE. AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE REPEATED AND RESULTS FOR SOME SAMPLES WERE CORRECTED. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE WITH DISCREPANT ALT RESULTS. THIS SAMPLE INITIALLY RESULTED IN AN ALT VALUE OF 5 U/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON 25-NOV-2022, RESULTING IN A VALUE OF 32 U/L. THE REPEAT VALUE WAS DEEMED CORRECT AND A CORRECTED REPORT WAS ISSUED. THE ALT REAGENT LOT NUMBER WAS 66105201, WITH AN EXPIRATION DATE OF 30-NOV-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959887 ↗