Aspartate Aminosransferase acc. to IFCC with pyridoxal phosphate activation 08056838190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336121023), received between Jul 3, 2023 and Jan 10, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High 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 4 most recent of 4 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 AST. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE ALT ASSAY. FOR AST: THE INITIAL RESULT WAS 243 U/L. THE REPEAT RESULTS USING THE SAME ANALYZER WERE 247 U/L AND 249 U/L. THE REPEAT RESULTS USING TWO COBAS C311 ANALYZERS WERE 66.9 U/L, 70 U/L, AND 70 U/L. ON (B)(6) 2024, A NEW SAMPLE FROM THE PATIENT HAD RESULTS OF 195 U/L AND 200 U/L. THE RESULT FROM THE COBAS C311 ANALYZER WERE 64 U/L AND 65.4 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 21127332 ↗
• MalfunctionSep 3, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION (ASTP) RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 35.8 UI/L WITH A DATA FLAG. THE REPEAT RESULT WITH AN AUTOMATIC 1:10 DILUTION WAS 62.4 UI/L. THE REPEAT RESULTS WITH NO DILUTION WERE 24.9 UI/L AND 25.3 UI/L. THE RESULT OF 25 UIU/L WAS BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130302 ↗
• MalfunctionFeb 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ASTPM ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION RESULTS FOR 2 PATIENT SAMPLES ON A COBAS PURE C 303 ANALYTICAL UNIT. FOR SAMPLE 1, THE INITIAL AST RESULT WAS 70.7 U/L. THE SAMPLE WAS REPEATED ON A COBAS INTEGRA ANALYZER AND THE REPEAT RESULT WAS 45.7 U/L. FOR SAMPLE 2, THE INITIAL AST RESULT WAS 75.0 U/L. THE SAMPLE WAS REPEATED ON A COBAS INTEGRA ANALYZER AND THE REPEAT RESULT WAS 35.7 U/L. THE EXACT DATES OF TESTING FOR SAMPLE 2 WERE NOT PROVIDED. THE COBAS INTEGRA RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798188 ↗
• MalfunctionJul 3, 2023High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION (ASTP) ON A COBAS PRO C 503 ANALYTICAL UNIT COMPARED TO A DXC 700 AU ANALYZER. THE RESULT FROM THE C503 ANALYZER WAS 385 U/L. THE RESULT FROM A DXC 700 AU ANALYZER WAS 181.99 U/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17250596 ↗