Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation 20764949322Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630913855), received between Jul 26, 2019 and Nov 26, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ASPARTATE AMINOTRANSFERASE (AST) RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THIS MEDWATCH WILL COVER AST. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CALCIUM RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LACTATE RESULTS, AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LDH RESULTS. THE DOCTOR QUESTIONED THE RESULTS AS THEY WERE HIGH AND DID NOT MATCH THE CLINICAL STATUS OF OUTPATIENTS IN "NORMAL" CONDITION. NO SPECIFIC SAMPLE RESULTS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657156 ↗
• MalfunctionDec 30, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST) ON A COBAS 8000 C 502 MODULE. THE SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 93.9 U/L. THE PATIENT QUESTIONED THE RESULT, SO THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN AN AST VALUE OF 20.6 U/L. A SECOND TUBE COLLECTED AT THE SAME TIME WAS ALSO REPEATED ON A SECOND ANALYZER ON (B)(6) 2024, RESULTING IN A VALUE OF 19.9 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21038996 ↗
• MalfunctionOct 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ASSAY RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS 6000 C 501 (UL) V. THE REPORTER PROVIDED EXAMPLES OF QUESTIONABLE ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ASTL) AND CREP GEN.2 (CREP2) RESULTS. THIS MEDWATCH IS FOR THE ASPARTATE AMINOTRANSFERASE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE CREATININE PLUS VER.2 ASSAY. THE INITIAL RESULT FROM THE ANALYZER WAS 65 U/L. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 26 U/L. THE REPEAT RESULT WAS DEEMED CORRECT. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLE WAS RERUN BECAUSE OF MULTIPLE INVALIDATING FLAGS FOR OTHER ASSAYS. THE REPORTER SAID THEY ACCIDENTALLY RAN A WHOLE BLOOD PATIENT SAMPLE FOR A COMPLETE METABOLIC PANEL (CMP) ASSAY BEFORE THE REPORTED PATIENT SAMPLE WAS RUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482619 ↗
• MalfunctionJan 23, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ASTL AND ALTL ON AN INTEGRA 400 PLUS SYSTEM. THE CUSTOMER NOTED THAT THE PATIENT SAMPLE WAS ICTERIC. THIS MEDWATCH WILL APPLY TO THE AST ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ALT ASSAY. THE SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 77 U/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED TWICE, RESULTING IN AST VALUES OF 279 U/L WITH A DATA FLAG AND 715 U/L WITH A DATA FLAG. THE SAMPLE WAS PLACED IN A CUP AND REPEATED TWICE, RESULTING IN AST VALUES OF 731 U/L WITH A DATA FLAG AND 732 U/L WITH A DATA FLAG. THE SAMPLE INITIALLY RESULTED IN AN ALT VALUE OF 36 U/L WITH A DATA FLAG AND IT REPEATED AS 1027 U/L WITH A DATA FLAG. THE SAMPLE WAS PLACED IN A CUP AND REPEATED TWICE, RESULTING IN ALT VALUES OF 1044 U/L WITH A DATA FLAG AND 1063 U/L WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18564147 ↗
• MalfunctionAug 23, 2021Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ISSUES WITH CONTROL RECOVERY AND PROFICIENCY SURVEY RECOVERY FOR ASTL ASPARTATE AMINOTRANSFERASE - PYRIDOXAL PHOSPHATE ACTIVATED ON THE COBAS INTEGRA 400 PLUS (SERIAL NUMBER (B)(4)) AND AN UNKNOWN COBAS 6000 SYSTEM (SERIAL NUMBER UNKNOWN) AT A SECOND SITE. THE REPORTER REPEATED PATIENT SAMPLES IN ORDER TO TROUBLESHOOT THE ISSUE AND FOUND DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES. THE FIRST SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 18 U/L WHEN TESTED ON THE INTEGRA 400 PLUS ANALYZER AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE ASSAY WAS RECALIBRATED AND THE SAMPLE WAS THEN REPEATED ON THE INTEGRA ON (B)(6) 2021, RESULTING IN A VALUE OF 28 U/L. THE 28 U/L VALUE WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS ALSO REPEATED THREE TIMES ON A COBAS 6000 SYSTEM AT A SECOND SITE ON (B)(6) 2021, RESULTING IN VALUES OF 30 U/L, 22 U/L, AND 18 U/L. THE FIELD SERVICE ENGINEER CHECKED THE INTEGRA ANALYZER OPTICS AND CHANGED THE HALOGEN LAMP. CONTROL RECOVERY IMPROVED AFTER THIS. THE CUSTOMER THEN ENCOUNTERED ISSUES WITH THE SECOND, THIRD, AND FOURTH COMPLAINED SAMPLES. THE SECOND SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 18 U/L W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355478 ↗
• MalfunctionJul 26, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. DISCREPANT LOW RESULTS WERE GENERATED BY A COBAS 6000 C (501) MODULE. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: THREE SAMPLES WITH ERRONEOUS RESULTS FOR ASTL ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830157 ↗

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-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-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-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