Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation 5850797190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630928927), received between Sep 12, 2024 and Apr 2, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALANINE AMINOTRANSFERASE ACC. TO IFCC (ALT) RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. THE CUSTOMER SUSPECTED AN INTERFERENCE. THE INITIAL RESULT WAS 0.2 U/L. THE REPEAT RESULT WITH A DECREASED SAMPLE VOLUME WAS -3.7 U/L WITH A DATA FLAG. THE REPEAT RESULT WITH AN INCREASED SAMPLE VOLUME WAS 1.4 U/L. THE RESULT USING THE J&J (DRY CHEMICAL TEST) METHOD WAS 43.8 U/L. THE CUSTOMER TESTED THE SAMPLE USING THE ALTP GEN.2 REAGENT ON A COBAS PRO C503 ANALYZER AND THE RESULT WAS 71.8 U/L THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752473 ↗
• MalfunctionNov 4, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION ON A COBAS 8000 C 701 MODULE. ALL QUESTIONED SAMPLES HAD INITIAL ALT VALUES < 5 U/L. THE SAMPLES WERE REPEATED ON OTHER ANALYZERS AFTER RE-CENTRIFUGATION AND THE RESULTS WERE SLIGHTLY HIGHER. THE CUSTOMER PROVIDED ONE EXAMPLE OF A PATIENT SAMPLE WITH DISCREPANT ALT RESULTS. THE CUSTOMER INDICATED THE SAMPLE WAS HEMOLYZED. THE SAMPLE INITIALLY RESULTED IN AN ALT VALUE OF 5 U/L. THE SAMPLE WAS RECENTRIFUGED AND REPEATED TWICE ON A SECOND ANALYZER, RESULTING IN ALT VALUES OF 24.6 U/L AND 24.6 U/L. THE SAMPLE WAS REPEATED ON A THIRD ANALYZER, RESULTING IN A VALUE OF 24.3 U/L. THE SAMPLE WAS ALSO REPEATED ON A SIEMENS INSTRUMENT, RESULTING IN AN ALT VALUE OF 30.62 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598840 ↗
• MalfunctionSep 12, 2024False Negative Result; Low Test Results; False Negative Result; Low Test Results

  THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR 3 SAMPLES FROM 1 PATIENT TESTED FOR ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ALT) ON A COBAS 8000 C 702 MODULE. THE PATIENT HAD A LIVER TRANSPLANT IN (B)(6) 2024. FOLLOWING THE TRANSPLANT, THE PATIENT WAS TESTED FOR ALT "MULTIPLE TIMES" BY 2 OTHER METHODS AND THE RESULTS WERE ALL "NORMAL" BUT THE AST RESULTS WERE ELEVATED. THE C702 MODULE WAS INSTALLED AT THE CUSTOMER SITE IN (B)(6) 2024. THE CUSTOMER RAN THE SAMPLES THAT WERE DRAWN IN (B)(6) 2024 ON THE C702 MODULE AND THE RESULTS WERE CONSISTENT WITH THE ALT RESULTS FROM THE OTHER METHODS. THE CUSTOMER SUSPECTS AN INTERFERENCE AS THE PATIENT¿S AST RESULTS WERE HIGH BUT THE ALT RESULTS WERE "NORMAL." NOTE: THE UNIT OF MEASURE WAS NOT PROVIDED. SAMPLE 1: THE INITIAL RESULT WAS 34.9. THE RESULT FROM A 1:10 DILUTION WAS 27.5. THE ALTLP RESULT WAS 44.4. SAMPLE 2: THE INITIAL RESULT WAS 35.9. THE RESULT FROM A 1:10 DILUTION WAS 30.8. THE ALTLP RESULT WAS 47.1. SAMPLE 3: THE INITIAL RESULT WAS 36.4. THE RESULT FROM A 1:10 DILUTION WAS 29.4. THE ALTLP RESULT WAS 44.2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20205614 ↗