Events

Recall of Device Recall D744 Chloride membrane

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer America 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
    35649
  • Event Risk Class
    Class 3
  • Event Number
    Z-1314-06
  • Event Initiated Date
    2005-02-01
  • Event Date Posted
    2006-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46548
  • 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
    in vitro diagnostic - Product Code CGZ
  • Reason
    The ci membrane units generate too low values for status and sensitivity during calibration.
  • Action
    The recalling firm sent a letter, dated 2/05, to all of their consignees.The letter instructed the customers to discontinue use of the product and discard any remaining stock which they had on hand. The letter was accompanied by replacement chloride membranes to replace the customer''s portion of the suspect lot.

Device

Device Recall D744 Chloride membrane

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA