Ethanol Gen2 3183777190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630918959), received between Apr 29, 2022 and Jul 23, 2025 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 6 PATIENTS' SAMPLES TESTED FOR ETHANOL GEN.2 (ETOH2) ASSAY ON A COBAS INTEGRA 400 PLUS ANALYZER. SAMPLE 1: INITIAL RESULT: 10.0 MG/DL. 1ST REPEAT RESULT: 5.4 MG/DL. SAMPLE 2: INITIAL RESULT: 9.0 MG/DL. 1ST REPEAT RESULT: 4.7 MG/DL. ON (B)(6) 2025: 2ND REPEAT RESULT: 3.8 MG/DL. SAMPLE 3: INITIAL RESULT: 10.1 MG/DL. 1ST REPEAT RESULT: 5.3 MG/DL. ON (B)(6) 2025: 2ND REPEAT RESULT: 3.9 MG/DL. SAMPLE 4: INITIAL RESULT: 9.2 MG/DL. 1ST REPEAT RESULT: 5.0 MG/DL. ON (B)(6) 2025: SAMPLE 5: INITIAL RESULT: 11.7 MG/DL. REPEAT RESULT: 1.0 MG/DL. SAMPLE 6: INITIAL RESULT: 13.3 MG/DL. REPEAT RESULT: 3.1 MG/DL. THE CUSTOMER QUESTIONED THE INITIAL RESULTS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY, AND THE SAMPLES WERE REPEATED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574602 ↗
• MalfunctionJul 8, 2025Suction Problem; Low Test Results; Suction Problem; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ETHANOL GEN.2 RESULT FROM THE COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 10 MG/DL, ACCOMPANIED BY A DATA FLAG. THE PHYSICIAN QUESTIONED THE INITIAL RESULT WAS THE PATIENT NOTED THAT THE PATIENT WAS POTENTIALLY UNDER THE INFLUENCE. A NEW SAMPLE WAS COLLECTED, AND THE RESULT WAS OVER 400 MG/DL. THE INITIAL SAMPLE WAS REPEATED, AND THE RESULT WAS 460 MG/DL, WHICH WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435565 ↗
• MalfunctionMar 4, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ETOH2 RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT FROM A SERUM SAMPLE WAS 0.059 G/L. THE REPEAT RESULT FROM THE SERUM SAMPLE WAS 1.073 G/L. THE RESULT FROM A PLASMA SAMPLE WAS 1.142 G/L. ON 06-FEB-2024, THE SAME SAMPLES WERE REPEATED. THE SERUM SAMPLE HAD A REPEAT RESULT OF 0.931 G/L AND THE PLASMA SAMPLE HAD A REPEAT RESULT OF 1.053 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825448 ↗
• MalfunctionApr 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ETOH2 ETHANOL GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL ETOH2 RESULT WAS 17.4 MMOL/L. THE FIRST REPEAT RESULT WAS 14.8 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 0.5 MMOL/L. THE SAMPLE WAS REPEATED AGAIN ON THE ORIGINAL MODULE AND THE RESULT WAS 0.2 MMOL/L. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) TESTING WAS CARRIED OUT ON THE SAMPLE AND THE ETOH RESULT WAS <2. THE DATE OF TESTING AND THE UNITS OF MEASUREMENT WERE REQUESTED BUT NOT PROVIDED. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SECOND REPEAT RESULT AND THE RESULT FROM THE OTHER MODULE WERE DEEMED CORRECT. THE ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16819804 ↗
• MalfunctionApr 29, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ETOH2 ETHANOL GEN.2 (ETOH2) RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS 6000 C (501) MODULE WITH SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS QUESTIONED BY THE PHYSICIAN WHO STATED THAT THE RESULT DID NOT FIT THE PATIENT'S CLINICAL PICTURE. THE REPORTER USED A PLASMA AND SERUM SAMPLE FROM THE PATIENT. ON (B)(6) 2022, THE INITIAL RESULT OF THE INITIAL PLASMA SAMPLE FROM LINE 2 AT 11:08 WAS 43.3 MG/DL. ON (B)(6) 2022, THE FIRST REPEAT RESULT OF THE INITIAL PLASMA SAMPLE FROM LINE 2 AT 5:08 WAS -1.7 MG/DL WITH A DATA FLAG. THE SECOND REPEAT RESULT OF THE INITIAL PLASMA SAMPLE FROM LINE 2 AT 5:08 WAS 0.6 MG/DL WITH A DATA FLAG. THE REPORTER STATED THAT A REAGENT PACK WITH A LOW VOLUME OF TESTS WAS USED FOR THESE RERUNS. ON (B)(6) 2022, THE THIRD REPEAT RESULT OF THE INITIAL PLASMA SPECIMEN AT 8:57 FROM LINE 2 WAS 2.6 MG/DL. THE INITIAL RESULT OF A SERUM SPECIMEN AT 8:57 FROM LINE 2 WAS 2.6 MG/DL. THE REPORTER STATED THAT HE USED A NEW REAGENT PACK IN LINE 2 FOR THESE TESTS. ON (B)(6) 2022, THE SECOND REPEAT RESULT OF THE SERUM SPECIMEN AT 9:49 FROM LINE 1 WAS 0.0 MG/DL. THE FOURTH REPEAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14249270 ↗

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