Aspartate Aminotransferase acc to IFCC with pyridoxal phosphate activation 4467493190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630920549), received between Aug 29, 2018 and Apr 17, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ASTL/PYP RESULTS FROM THE COBAS 4000 C311 STAND ALONE SYSTEM. PATIENT 1'S INITIAL RESULT WAS 12.9 U/L, AND THE REPEAT RESULTS OF 20.3 U/L AND 21.7 U/L WITH A NEW CALIBRATION LOT ON 27-MAR-2025. PATIENT 2'S INITIAL RESULT WAS 16.2 U/L, AND THE REPEAT RESULTS OF 22.6 U/L AND 19.5 U/L WITH A NEW CALIBRATION LOT ON 27-MAR-2025. THE RESULT OF 22.6 U/L FOR PATIENT 2 WAS DEEMED TO BE CORRECT. THE CUSTOMER DISCOVERED THE QUESTIONABLE RESULTS DURING METHOD COMPARISON TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854485 ↗
• MalfunctionJan 9, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION (AST) ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 46 U/L. THIS RESULT DID NOT CORRESPOND TO THE ALT RESULT (12 U/L) OR THE PATIENT¿S HISTORICAL RESULTS. THE REPEAT RESULT WAS 19 U/L. ON (B)(6) 2024 THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 19 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114953 ↗
• MalfunctionAug 29, 2018Low Test Results; Low Test Results

  THE CUSTOMER ORIGINALLY COMPLAINED ABOUT QUESTIONABLE CREP2 CREATININE PLUS VER.2 TESTED ON BOTH A COBAS 6000 C (501) MODULE AND A COBAS 8000 (UNSPECIFIED MODULE) COMPARED TO AN ABBOTT SYSTEM. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR CREP2, ASTLP ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION, ALTLP ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION, AND GGT-2 -GLUTAMYLTRANSFERASE VER.2 STANDARDIZED AGAINST IFCC / SZASZ. THIS MEDWATCH WILL COVER ASTLP. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON CREP2. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON GGT-2. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON ALTLP. PLEASE REFER TO THE ATTACHMENT TO THIS MEDWATCH FOR PATIENT DATA. THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THE PATIENT WAS SENT TO THE HOSPITAL DUE THE INITIAL HIGH CREP2 RESULT, BUT THERE WAS NO ALLEGATION THAT THE PATIENT WAS ADVERSELY AFFECTED. THE COBAS C501 SERIAL (B)(4). THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC INFORMATION ON THE COBAS 8000 SYSTEM. A PRELIMINARY ASSESSMENT OF THE CASE STATED THAT BASED ON PREVIOUS ELECTROPHORESIS TE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7827933 ↗

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