Alanine Aminotransferase acc. to IFCC II 08104697190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613336130513), received between Jul 23, 2024 and Dec 29, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Signal Artifact/Noise; Unable to Obtain Readings; Signal Artifact/Noise; Unable to Obtain Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALTP GEN.2 RESULTS FOR ONE PATIENT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 18.5 U/L. THE REPEAT RESULT USING A COBAS 8000 ANALYZER WAS 34 U/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905280 ↗
• MalfunctionOct 15, 2025Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ASPARTATE AMINO TRANSFERASE AND ALTP GEN.2 RESULTS FOR ONE PATIENT FROM THE COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER SUSPECTED THAT AN INTERFERENCE FROM THE PATIENT¿S MEDICATION WAS CAUSING INCORRECT RESULTS AND DATA FLAGS. THE MEDWATCH IS FOR THE ALTP GEN.2 ASSAY. REFER TO THE MEDWATCH WITH A1-PATIENT IDENTIFIER (B)(6) FOR THE ASPARTATE AMINO TRANSFERASE ASSAY. THE INITIAL RESULTS HAD ">KIN3" DATA FLAGS. AFTER THE INITIAL RESULTS, THE CUSTOMER RETESTED THE SAMPLE WITH VARIOUS DILUTIONS. THE CUSTOMER COULD NOT PROVIDE SPECIFIC DATA BUT STATED ALL OF THE RESULTS WERE ACCOMPANIED BY THE DATA FLAG. THE CUSTOMER RETESTED THE PATIENT SAMPLE AS IF IT WERE QC MATERIAL. THE ALT RESULT WAS -7.35 U/L WITH A DATA FLAG. THE AST RESULT WAS 4.07 U/L WITH A DATA FLAG. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT, AND THE RESULTS WERE THE SAME, WITH THE DATA FLAG. NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23281565 ↗
• MalfunctionJul 29, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALTP GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN ALT VALUE OF 7.06 U/L. THE SAMPLE WAS REPEATED, RESULTING IN AN ALT VALUE OF 11.0 U/L ACCOMPANIED BY A DATA FLAG INDICATING A REACTION ISSUE. THE SAMPLE WAS REPEATED USING DECREASED SAMPLE VOLUME, RESULTING IN AN ALT VALUE OF > 8069 U/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED, RESULTING IN AN ALT VALUE OF 9.54 U/L ACCOMPANIED BY A DATA FLAG INDICATING A REACTION ISSUE. THE SAMPLE WAS DILUTED 1:10 AND REPEATED, RESULTING IN AN ALT VALUE OF > 8097 U/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:50 AND REPEATED ON (B)(6) 2025, RESULTING IN AN ALT VALUE OF 9124 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644662 ↗
• MalfunctionMay 2, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALTP GEN.2 (ALT) AND ASPARTATE AMINO TRANSFERASE (AST) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL ALT AND AST RESULTS PRODUCED DATA FLAGS. IT WAS REPORTED THAT THE REPEATED RESULTS CONFIRMED THE ISSUE WAS "SAMPLE SPECIFIC". AN INTERFERENCE BETWEEN THE ASSAYS AND THE PATIENT SAMPLE WAS SUSPECTED. THE NUMERICAL RESULTS WERE NOT PROVIDED. THIS MEDWATCH WILL APPLY TO THE ALTP GEN.2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ASPARTATE AMINO TRANSFERASE ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949333 ↗
• MalfunctionDec 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALTP GEN.2 RESULTS FOR 2 PATIENT SAMPLES AND QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. ALTP RESULTS: PATIENT 1: THE INITIAL RESULT WAS 54 U/L. THE RESULT WITH THE NEW REAGENT LOT WAS 95 U/L. THE REPEATED RESULT WITH THE INITIAL REAGENT LOT WAS 114 U/L. PATIENT 2: THE INITIAL RESULT WAS 236 U/L. THE RESULT WITH THE NEW REAGENT LOT WAS 427 U/L. THE REPEATED RESULT WITH THE INITIAL REAGENT LOT WAS 429 U/L. LDH RESULTS: PATIENT 3: ON (B)(6) 2024, THE INITIAL RESULT WAS 885 U/L. THE RESULT WITH THE NEW REAGENT LOT WAS 518 U/L. THE REPEATED RESULT WITH THE INITIAL REAGENT LOT WAS 564 U/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED A LOT-TO-LOT COMPARISON STUDY WITH THE ALLEGED SAMPLES USING NEW REAGENT LOTS. THE CUSTOMER NOTICED THE DISCREPANCIES AND REPEATED THE SAMPLES ON ANOTHER MODULE USING THE SAME REAGENT LOTS THAT WERE USED TO OBTAIN THE INITIAL RESULTS. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT AS THEY WERE COMPARABLE WITH THE RESULTS OBTAINED DURING THE LOT-TO-LOT COMPARISON. THIS MEDWATCH WILL APPLY TO THE ALTP GEN.2 ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894366 ↗
• MalfunctionDec 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Insufficient Device Problem Information; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALTP GEN.2 RESULTS FOR 2 PATIENT SAMPLES AND QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. ALTP RESULTS: PATIENT 1: ON (B)(6) 2024 THE INITIAL RESULT WAS 54 U/L. THE RESULT WITH THE NEW REAGENT LOT WAS 95 U/L. THE REPEATED RESULT WITH THE INITIAL REAGENT LOT WAS 114 U/L. PATIENT 2: ON (B)(6) 2024 THE INITIAL RESULT WAS 236 U/L. THE RESULT WITH THE NEW REAGENT LOT WAS 427 U/L. THE REPEATED RESULT WITH THE INITIAL REAGENT LOT WAS 429 U/L. LDH RESULTS: PATIENT 3: ON (B)(6) 2024, THE INITIAL RESULT WAS 885 U/L. THE RESULT WITH THE NEW REAGENT LOT WAS 518 U/L. THE REPEATED RESULT WITH THE INITIAL REAGENT LOT WAS 564 U/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED A LOT-TO-LOT COMPARISON STUDY WITH THE ALLEGED SAMPLES USING NEW REAGENT LOTS. THE CUSTOMER NOTICED THE DISCREPANCIES AND REPEATED THE SAMPLES ON ANOTHER MODULE USING THE SAME REAGENT LOTS THAT WERE USED TO OBTAIN THE INITIAL RESULTS. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT AS THEY WERE COMPARABLE WITH THE RESULTS OBTAINED DURING THE LOT-TO-LOT COMPARISON. THIS MEDWATCH WILL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894088 ↗
• MalfunctionJul 23, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALTP GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 9.48 U/L. THE PHYSICIAN REQUESTED THE SAMPLE BE REPEATED AS THE RESULT WAS NOT CONSISTENT WITH THE CLINICAL STATUS OF THE PATIENT. THE REPEATED RESULT WAS 22.8 U/L WITH A DATA FLAG. THE REPEATED RESULT WITH A DECREASED SAMPLE VOLUME WAS "AROUND 2000 U/L".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810265 ↗