Ethanol Gen.2 08445672190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336157817), received between Jul 23, 2025 and Jul 23, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ETHANOL GEN.2 RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. ON (B)(6) 2025: PATIENT SAMPLE 1 THE INITIAL RESULT FROM THE ANALYZER WAS -0.00878 G/L WITH AN INVALIDATING DATA FLAG. THIS RESULT WAS REPORTED AS <0.1 G/L. THE REPEAT RESULT FROM ANOTHER C 503 ANALYZER WAS <0.1 G/L. ON (B)(6) 2025: PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE ANALYZER WAS 0.0439 G/L WITH AN INVALIDATING DATA FLAG. THE REPEAT RESULT FROM THE ANALYZER WAS -0.00110 G/L WITH AN INVALIDATING DATA FLAG. THE RESULTS DO NOT AGREE WITH THE PATIENTS' CLINICAL PRESENTATION OF ACUTE ALCOHOL INTOXICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576453 ↗

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