cobas 6000 core unit 4745868001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630924691), received between Aug 9, 2018 and Apr 17, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HBSAG II RESULT FROM THE COBAS 6000 CORE UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 1.24 COI (REACTIVE). THE REPEAT RESULT WAS 0.68 COI (NON-REACTIVE). THE QUESTIONABLE RESULT WAS NOT RELEASED OUTSIDE OF THE LABORATORY AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24914465 ↗
• MalfunctionFeb 18, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN.2 (LPA2) ASSAY RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS 6000 CORE UNIT 150 (JP VERS.). SAMPLE 1 THE INITIAL RESULT WAS 285.30 NMOL/L WITH AN INVALIDATING DATA FLAG. THE FIRST REPEAT RESULT IN DECREASED MODE WAS 175.81 NMOL/L. THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE AT MANUAL 2-FOLD DILUTION WAS 71.57 NMOL/L WITH A FINAL COMPUTED RESULT OF 143.14 NMOL/L. THE THIRD REPEAT RESULT IN THE ORIGINAL MODE WAS 229.74 NMOL/L. SAMPLE 2 THE INITIAL RESULT WAS 249.26 NMOL/L WITH AN INVALIDATING DATA FLAG. THE FIRST REPEAT RESULT IN DECREASED MODE WAS 140.22 NMOL/L. THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE AT MANUAL 2-FOLD DILUTION WAS 68.22 NMOL/L WITH A FINAL COMPUTED RESULT OF 136.44 NMOL/L. THE THIRD REPEAT RESULT IN THE ORIGINAL MODE WAS 181.24 NMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AS THEY DID NOT MATCH THE PATIENTS' CLINICAL DIAGNOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399252 ↗
• MalfunctionMay 18, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HCG+BETA ELECSYS RESULT FROM THE COBAS 6000 CORE UNIT. THE INITIAL RESULT WAS 6.66 MIU/ML, THE REPEAT RESULT WAS <0.1MIU/ML, AND THE SECOND REPEAT RESULT WAS <0.1MIU/ML, THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER WAS 64377000 WITH AN EXPIRATION DATE OF 30-NOV-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954423 ↗
• MalfunctionJan 18, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR SODIUM (NA) ON A COBAS 6000 CORE UNIT. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 5 PATIENT SAMPLES. PATIENT 1 (B)(6) INITIAL RESULT WAS 153 MMOL/L. THE REPEAT WAS 143 MMOL/L. PATIENT 2 (B)(6) INITIAL RESULT WAS 138 MMOL/L. THE REPEAT WAS 132 MMOL/L. PATIENT 3 (B)(6) INITIAL RESULT WAS 136 MMOL/L. THE REPEAT WAS 129 MMOL/L. PATIENT 4 (B)(6) INITIAL RESULT WAS 168 MMOL/L. THE REPEAT WAS 158 MMOL/L. PATIENT 5 (B)(6) INITIAL RESULT WAS 154 MMOL/L. THE REPEAT WAS 149 MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND AMENDED UPON COMPLETION OF REPEAT TESTING ON A DIFFERENT LINE. THE NA ELECTRODE LOT NUMBERS WERE D7217 AND D7206. THE EXPIRATION DATES WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16198719 ↗
• MalfunctionOct 26, 2018Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER COMPLAINED OF A SOFTWARE ISSUE ON THEIR COBAS 6000 SERIES SYSTEM COBAS 6000 CORE UNIT THAT MAY IMPACT THE INTERPRETATION OF PATIENT RESULTS. THE CUSTOMER PROVIDED DATA THAT WAS A REPORTABLE MALFUNCTION FOR 1 PATIENT'S UA2 URIC ACID VER.2 DATA, FOR 1 PATIENT'S ALT ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION DATA, AND FOR 1 PATIENT'S CREJ2 CREATININE JAFFÉ GEN.2 DATA. THE SOFTWARE VERSION FOR THE COBAS 6000 CORE UNIT WAS 06-02. FOR URIC ACID PATIENT'S RESULT, THE RESULT DISPLAYED ON THE ANALYZER WAS 6.3 MG/DL WHILE THE LABORATORY INFORMATION SYSTEM (LIS) RESULT DISPLAYED WAS 62.3 MG/DL. FOR THE ALT PATIENT'S RESULT, THE RESULT DISPLAYED ON THE ANALYZER WAS 20.5 U/L WITH THE LIS RESULT DISPLAYED WAS 220.5 U/L. FOR THE CREJ2 PATIENT'S RESULT, THE RESULT DISPLAYED ON THE ANALYZER WAS 0.94 MG/DL WITH THE LIS RESULT DISPLAYED WAS 2.94 MG/DL. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. A FIELD ENGINEERING SPECIALIST REPLACED A PRINTED CIRCUIT BOARD BUT THE ISSUE WAS NOT RESOLVED. WHILE CONDUCTING THE INVESTIGATION IT WAS BELIEVED THE ISSUE WAS WITH THE CONFIGURATION OF THE CUST

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8010772 ↗
• MalfunctionAug 9, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FOR 2 PATIENT SAMPLES TESTED ON A COBAS 6000 SERIES SYSTEM, COBAS 6000 CORE UNIT. FOR PATIENT 1 THE INITIAL SODIUM RESULT WAS 153 MMOL/L. ON (B)(6) 2018 A REPEAT SODIUM RESULT OF 141.5 MMOL/L WAS OBTAINED FROM THE SAME ANALYZER WHILE A REPEAT SODIUM RESULT OF 142.1 MMOL/L WAS OBTAINED FROM ANOTHER COBAS ANALYZER. FOR PATIENT 2 ON (B)(6) 2018, THE INITIAL SODIUM RESULT WAS 154.6 MMOL/L WITH REPEAT SODIUM RESULTS OF 142.5 MMOL/L AND 142.9 MMOL/L. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SODIUM ELECTRODE LOT INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7767203 ↗

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-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-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-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.