Events

Recall of Device Recall OMNI

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

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
    34180
  • Event Risk Class
    Class 2
  • Event Number
    Z-0361-06
  • Event Initiated Date
    2005-12-09
  • Event Date Posted
    2006-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43233
  • 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
    Whole Blood Hemoglobin Determination - Product Code KHG
  • Reason
    Potential for hemoglobin derivatives which are outside of the quality control (qc) limits to not engage the auto lock out feature of the system for 02hb, cohb, hhb, methb or so2.
  • Action
    Consignees were notified via letter dated 12/9/05.

Device

Device Recall OMNI
  • Model / Serial
    All units with Co-Oximetry (COOX) modules.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, Florida, Georgia, Indiana, Iowa, New Hampshire, Michigan, New York, North Carolina, North Dakota, Pennsylvania, Texas and Washington.
  • Product Description
    Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA