Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation 5850819190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630928934), received between Sep 22, 2021 and Nov 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 reports).

7 other recalls cover devices cleared under the same FDA submission (K951595); they may or may not involve this specific model.

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.

• MalfunctionNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 8000 C702 MODULE. THE CUSTOMER SUSPECTED INTERFERENCE, AS THE SAMPLE IN QUESTION WAS COLLECTED 17 HOURS AFTER THE PATIENT HAD RECEIVED RED BLOOD CELLS DUE TO BEING ANEMIC. THE INITIAL AST (ASPARTATE AMINOTRANSFERASE) RESULT WAS 17.6 U/L WITH AN ANALYZER ALARM. THE INITIAL ALT (ALANINE AMINOTRANSFERASE) RESULT WAS 11.3 U/L WITH AN ANALYZER ALARM. DUE TO THE ALARM, A 1:10 AUTO DILUTION WAS PERFORMED. THE RESULT FOR AST WAS 2.2 U/L, AND THE RESULT FOR ALT WAS 10.3 U/L. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025, AND THE AST AND ALT RESULTS HAD NO FLAGS. NO SPECIFIC DATA WAS PROVIDED. THIS MEDWATCH IS FOR AST (ASPARTATE AMINOTRANSFERASE). REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE ALT (ALANINE AMINOTRANSFERASE) ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618537 ↗
• MalfunctionSep 6, 2024Mechanical Problem; Unable to Obtain Readings; Mechanical Problem; Unable to Obtain Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE AST RESULTS FROM A COBAS 8000 ANALYZER. THE CUSTOMER ALLEGED THE RESULTS MIGHT NOT BE CORRECT DUE TO A POTENTIAL INTERFERENCE. THE PATIENT HAD SIMILAR RESULTS ONE MONTH AGO (NO SPECIFIC DATA PROVIDED) AND THE CUSTOMER BELIEVES THAT SOME SUBSTANCE SUCH AS A DRUG METABOLITE MAY BE AFFECTING THE RESULTS. THE INITIAL RESULT WAS 105 U/L WITH AN INVALIDATING DATA FLAG. THE REPEAT RESULT WITH A 1:5 DILUTION WAS 101.69 U/L WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155974 ↗
• MalfunctionApr 19, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF 1 PATIENT SAMPLE CONTAINING AN INTERFERING FACTOR THAT CAUSES A LOWER AST ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION RESULT, BUT THE ALT ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION RESULT IS ELEVATED. THE CUSTOMER SUSPECTS THE HIGH UREAL UREA/BUN RESULT MAY BE A FACTOR IN THIS RESULT PATTERN. THE PATIENT ALSO TESTED POSITIVE FOR COCAINE AND WAS SUSPECTED OF TYLENOL OVERDOSE. THE FOLLOWING RESULTS WERE FROM MULTIPLE HEPATIC PANELS FROM THE SAME PATIENT: THE ALT RESULT WAS 2029 U/L. THE AST RESULT WAS 76 U/L. THE BUN RESULT WAS 115 MG/DL. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER MODULE AND SERIAL NUMBER WERE REQUESTED, BUT NOT PROVIDED. THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142326 ↗
• MalfunctionSep 22, 2021High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH ASTL ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION ON A COBAS 8000 C (701) MODULE. THE SAMPLE VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE MEDICATION THE PATIENT WAS TAKING WAS SUSPECTED TO INTERFERE WITH THE ASSAY. THE FIRST SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 285 U/L AND REPEATED AS 23 U/L. THE 285 U/L VALUE WAS REPORTED TO THE PATIENT. DUE TO A NORMAL ALT VALUE, THE SAMPLE WAS REPEATED ON (B)(6) 2021, RESULTING IN AN AST VALUE OF 51 U/L. THE 51 U/L VALUE WAS ALSO REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE PATIENT STATED THAT THE HIGH VALUE OF 285 U/L IS EXPECTED ACCORDING TO HER MEDICAL SITUATION. THE SECOND SAMPLE WAS INITIALLY TESTED TWICE ON (B)(6) 2021, EACH TIME RESULTING IN A VALUE OF 320 U/L. THE SAMPLE WAS REPEATED AGAIN THAT SAME DAY, RESULTING IN A VALUE OF 270 U/L. ON (B)(6) 2021, THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF AROUND 140 U/L. THE SERIAL NUMBER OF THE C701 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511668 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951595. One submission often covers many models, so check the product and lot details in each record.

• Z-1675-2021 · Apr 26, 2021 · Open, Classified
  IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plas
• Z-0100-2017 · Jul 15, 2016 · Terminated
  Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone sys
• Z-0168-2014 · Sep 16, 2013 · Terminated
  COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed
• Z-0696-2013 · Nov 19, 2012 · Terminated
  Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
• Z-0012-2009 · Jun 11, 2008 · Terminated
  Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS I
• Z-0007-2009 · Jun 11, 2008 · Terminated
  Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122. An in-vitro diagnostic reagent system intended for use on
• Z-0667-03 · Feb 13, 2003 · Terminated
  COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345