Ethanol Gen.2 08057630190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336121221), received between Jul 20, 2023 and Feb 5, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVE QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ETHANOL GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER STATED THAT THE QUESTIONED RESULTS ARE FROM PATIENTS WHO HAS PHYSICAL SYMPTOMS OF ALCOHOL INTOXICATION. QUALITATIVE BREATH ALCOHOL CONCENTRATION (BREATHALYZER) MEASUREMENTS OF THESE PATIENTS ARE POSITIVE. ONE HOUR AFTER THE BREATHALYZER MEASUREMENTS, SAMPLES ARE COLLECTED FROM THESE PATIENTS AND HAVE ETHANOL RESULTS FROM THE C 503 ANALYZER THAT ARE BELOW THE MEASURING RANGE OF THE ASSAY. THE CUSTOMER PROVIDED SPECIFIC EXAMPLES FOR TWO PATIENTS. ON 08-MAR-2025, THE FIRST PATIENT WAS OBSERVED TO BE APPARENTLY INTOXICATED. THE FACILITY ADMINISTERED BREATHALYZER TESTING WITH A CDP7000 BREATHALYZER AND THE RESULT WAS 62 MG/100 ML OF ALCOHOL. FIVE MINUTES LATER, THE BREATHALYZER WAS REPEATED AND THE RESULT WAS 44 MG/100 ML OF ALCOHOL. A VENOUS SAMPLE WAS COLLECTED FROM THE PATIENT AND MEASURED ON THE C 503 SYSTEM, RESULTING IN AN ETHANOL VALUE OF < 10 MG/DL. ON (B)(6) 2025, THE SECOND PATIENT WAS OBSERVED TO BE APPARENTLY INTOXICATED. THE FACILITY ADMINISTERED BREATHALYZER TESTING WITH A CDP7000 BREATHALYZER AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270727 ↗
• MalfunctionJul 20, 2023High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM SAMPLE TESTED WITH ETHANOL GEN.2 (ETOH2) ASSAY ON A COBAS PRO C 503 ANALYZER. INITIAL RESULT: 137 MG/DL. THE PHYSICIAN QUESTIONED THE RESULT AND THE PATIENT DENIED USING ALCOHOL. THE SAMPLE WAS RERUN. RERUN RESULT: 0 MG/DL THE RERUN RESULT DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17363018 ↗

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