Aspartate Aminotransferase acc. to IFCC II 08104719190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336130537), received between Nov 7, 2024 and Oct 15, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ASPARTATE AMINO TRANSFERASE ASSAY. REFER TO THE MEDWATCH WITH A1-PATIENT IDENTIFIER (B)(6) FOR THE ALTP GEN.2 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 23281728 ↗
• 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 ASPARTATE AMINO TRANSFERASE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ALTP GEN.2 ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949322 ↗
• MalfunctionApr 18, 2025Low Test Results; Low Test Results

  ROCHE DIAGNOSTICS RECEIVED A CUSTOMER COMPLAINT REGARDING ALLEGED NON-REPRODUCIBLE ASTP2 ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 19.4 U/L. THE SAMPLE WAS REPEATED, BUT IT RESULTED IN NO VALUE, ONLY A FLAG INDICATING A REACTION ISSUE. THE SAMPLE WAS DILUTED 1:20 AND REPEATED, RESULTING IN AN AST VALUE OF 3934 U/L. THE SAMPLE WAS REPEATED TWO ADDITIONAL TIMES ON (B)(6) 2025, BUT EACH TIME IT DID NOT RESULT IN A VALUE, ONLY A FLAG INDICATING A REACTION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865197 ↗
• MalfunctionApr 1, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ASPARTATE AMINO TRANSFERASE RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.18 U/L. THE REPEAT RESULT WITH A 1:20 DILUTION WAS 3772 U/L WITH A DATA FLAG. THE NEXT DAY THE RESULT FROM A NEW SAMPLE HAD A HIGH RESULT ACCOMPANIED BY A DATA FLAG. NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741562 ↗
• MalfunctionNov 7, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ASPARTATE AMINO TRANSFERASE RESULTS FOR 1 PATIENT ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 923 U/L. THE PATIENT WAS SUSPECTED OF HAVING A NEUROMUSCULAR PATHOLOGY BUT WITHOUT THE ALTERATION OF THE OTHER RHABDOMYOLYSIS PARAMETERS. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 145 U/L. A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 967 U/L. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH A 1:10 DILUTION AND THE RESULT WAS 974 U/L. REPEAT TESTING WAS PERFORMED DUE TO THE INITIAL RESULTS NOT MATCHING THE PATIENT'S CLINICAL STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20633453 ↗