Events

Recall of cobas c 311 Analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Operations, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60282
  • Event Risk Class
    Class 2
  • Event Number
    Z-0310-2012
  • Event Initiated Date
    2011-10-26
  • Event Date Posted
    2011-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104939
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    The cobas c 311 analyzer software may incorrectly calculate the volume of the ise reference electrolyte solution remaining on the analyzer. in some cases the incorrect results obtained will not be flagged with any data alarms.
  • Action
    October 26, 2011 Urgent Medical Device Corrections were sent to all direct accounts in the USA that have installed the cobas c 311 analyzer and included a faxback form to be completed and faxed to 1-877-766-7452. Consignees were instructed to temporarily replace the ISE Reference Electrolyte bottle based upon the frequency calculated from the maximum number of ISE samples run per day and activate the yellow threshold alarm on the system. Customers with question and concerns are directed to call Roche Diagnostics Technical Support at 1-800-428-2366, available 24-hours, 7 days a week.

Device

cobas c 311 Analyzer
  • Model / Serial
    Serial Numbers:1050-16, 1040-08, 1041-06, 0927-16, 0918-05, 1048-02, 0812-12, 1058-09, 0925-20, 1044-19, 1041-05, 1043-15, 1056-18, 0812-09, 1038-07, 0814-10, 1041-19, 1170-04, 0929-08, 0919-16, 0814-03, 0926-11, 1035-01, 1034-19, 1035-10, 1174-19, 1176-03, 1067-02, 0919-17, 0920-05, 0927-13, 1060-17, 1060-05, 0927-17, 1044-18, 0812-10, 0811-20, 1041-20, 1174-04, 0925-05, 1060-01, 1062-09, 1066-20, 1174-07, 0814-15, 0814-17, 1053-16, 1054-02, 1034-02, 1052-16, 1052-19, 0918-06, 1052-13, 1052-20, 1052-15, 1034-07, 1043-10, 0811-15, 1054-03, 1061-08, 1043-06, 0926-10, 1044-06, 1034-03, 1052-09, 1043-12, 1055-01, 0929-09, 1038-05, 1034-01, 0810-19, 1054-20, 1062-07, 1059-20, 0814-16, 1043-14, 1062-08, 1054-01, 0929-07, 1038-06, 1056-19, 1057-03, 1169-20, 0926-19, 1067-01, 1038-04, 0925-06, 1043-08, 1043-13, 0812-11, 1057-05, 1060-06, 0926-16, and 1034-06.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including the states of Maryland and Texas.
  • Product Description
    cobas c 311 Analyzer, Part Number: 04826876001 || In-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA