cobas 6000 c501 module 7790198001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630946402), received between Feb 29, 2024 and Dec 11, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 reports).

10 other recalls cover devices cleared under the same FDA submission (K060373); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 60 PATIENTS' SAMPLES TESTED ON A COBAS 6000 C501 (UL) V MODULE. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES WERE PROVIDED. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 131 MMOL/L. REPEAT RESULT: 137 MMOL/L. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 131 MMOL/L. REPEAT RESULT: 139 MMOL/L. QC ISSUES AND ONGOING LOW NA VALUES PROMPTED THE REPEAT OF THE SAMPLES ON (B)(6) 2024. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. OUT OF THE 60 PATIENTS' RESULTS, REPORTEDLY, AN AMENDED REPORT WITH 46 CORRECT RESULTS WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906394 ↗
• MalfunctionOct 29, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS INTEGRA GLUCOSE HK GEN. 3 RESULTS FROM THE COBAS 6000 C 501 MODULE. SAMPLE 1 INITIAL RESULT WAS 24 MG/DL AND THE REPEAT RESULTS FROM ANOTHER ANALYZER WERE 91.6 MG/DL AND 91.9. THE REPEAT RESULT FROM THE ORIGINAL ANALYZER WAS 91.0 MG/DL. SAMPLE 2 INITIAL RESULT WAS 12.0 MG/DL AND THE REPEAT RESULT WAS 76.3 MG/DL. SAMPLE 3 INITIAL RESULT WAS 20 MG/DL AND THE REPEAT RESULT WAS 103 MG/DL. SAMPLE 4 INITIAL RESULT WAS 12 MG/DL AND THE REPEAT RESULT WAS 77 MG/DL. THE QUESTIONABLE RESULT FOR SAMPLE 1 WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561606 ↗
• MalfunctionOct 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE INITIAL SODIUM RESULT WAS 116 MMOL/L, THE INITIAL POTASSIUM RESULT WAS 3.41 MMOL/L, AND THE INITIAL CHLORIDE RESULT WAS 83.4 MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THE PATIENT WAS REDRAWN IN THE ER. THE RESULTS FOR THE NEW SAMPLE WERE SODIUM 140 MMOL/L, POTASSIUM 4.1 MMOL/L, AND CHLORIDE 105 MMOL/L. THE ORIGINAL SAMPLE WAS REPEATED ON THE SAME AND ANOTHER C501 ANALYZER. THE SODIUM RESULTS WERE 140 MMOL/L AND 139 MMOL/L, THE REPEAT POTASSIUM RESULTS WERE 4.07 MMOL/L AND 4.12 MMOL/L, AND THE REPEAT CHLORIDE RESULTS WERE 104.6 MMOL/L AND 104.0 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360154 ↗
• MalfunctionMar 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LOW ISE INDIRECT GEN 2 RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE SAMPLES WERE REPEATED ON A COBAS PURE ANALYZER AND THEN ON THE COBAS 6000 ANALYZER. SAMPLE 1 INITIAL RESULT WAS 130 MMOL/L AND THE REPEAT RESULTS WERE 138 MMOL/L ON A COBAS PURE ANALYZER AND 139 MMOL/L ON A COBAS 6000 ANALYZER. SAMPLE 2 INITIAL RESULT WAS 131 MMOL/L AND THE REPEAT RESULT WAS 139 MMOL/L ON A COBAS PURE ANALYZER. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847632 ↗
• MalfunctionFeb 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE, K ELECTRODE, AND CL ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THE INITIAL NA RESULT WAS 113 MMOL/L. THE REPEATED RESULT WAS 121 MMOL/L THIS RESULT WAS OUTSIDE OF THE LABORATORY'S TOLERANCE FOR A REPEAT SAMPLE SO THE SAMPLE WAS REPEATED AGAIN. THE SAMPLE WAS REPEATED ON A DIFFERENT ANALYZER AND THE RESULT WAS 128 MMOL/L. THIS RESULT WAS BELIEVED TO BE CORRECT. THE INITIAL K RESULT WAS 3.4 MMOL/L. THE REPEATED RESULT WAS 4.30 MMOL/L. THIS RESULT WAS OBTAINED ON A DIFFERENT ANALYZER AND WAS BELIEVED TO BE CORRECT. THE INITIAL CL RESULT WAS 75 MMOL/L. THE REPEATED RESULT WAS 90 MMOL/L. THIS RESULT WAS OBTAINED ON A DIFFERENT ANALYZER AND WAS BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED DUE TO THE INITIAL NA RESULT BEING MARKED AS CRITICAL IN THE CUSTOMER'S MIDDLEWARE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18811030 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060373. One submission often covers many models, so check the product and lot details in each record.

• Z-2476-2019 · Jul 18, 2019 · Terminated
  cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
• Z-1268-2018 · Dec 18, 2017 · Terminated
  c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 0503634
• Z-0909-2018 · Jul 18, 2017 · Terminated
  cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL +
• Z-0378-2018 · Jun 29, 2017 · Terminated
  Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - e 602 Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number
• Z-2049-2017 · Mar 21, 2017 · Terminated
  Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: Th
• Z-0096-2017 · Jul 15, 2016 · Terminated
  cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primar
• Z-1792-2014 · May 21, 2014 · Terminated
  cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay
• Z-1791-2014 · May 21, 2014 · Terminated
  cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay
• Z-0542-2009 · Sep 15, 2008 · Terminated
  Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.
• Z-0576-2008 · Dec 4, 2007 · Terminated
  Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.