Events

Recall of Device Recall Omni Microelectrode for cobas b221 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
    67549
  • Event Risk Class
    Class 2
  • Event Number
    Z-1315-2014
  • Event Initiated Date
    2014-02-28
  • Event Date Posted
    2014-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125702
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous ph and/or sodium results. other ion parameters are not affected.
  • Action
    Roche Diagnostics Operations sent an Urgent Medical Device Correction letter dated February 27, 2014 via UPS Ground (receipt required) to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed fax form and fax it to 1-888-345-0253. For questions contact Roche Customer Business Support Center at 1-800-428-5076.

Device

Device Recall Omni Microelectrode for cobas b221 analyzer
  • Model / Serial
    all serial numbers
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribution
    Worldwide Distribution - USA nationwide including PR and the country of Guam.
  • Product Description
    Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: || 03111873180 as a part of the following systems: || 1. 03337103001, cobas b 221<1>Roche OMNI S1 system || 2. 03337111001, cobas b 221<2>Roche OMNI S2 system || 3. 03337154001,cobas b 221<6>Roche OMNI S6 system || 4. 03337138001, cobas b 221<4>Roche OMNI S4 system || Product Usage: Usage: || Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

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