Events

Recall of Device Recall Dritek D7120, BGOX Cartridges Qualicheck2

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
    35664
  • Event Risk Class
    Class 3
  • Event Number
    Z-1406-06
  • Event Initiated Date
    2005-01-12
  • Event Date Posted
    2006-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46580
  • 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
    Bllod gas analyzers - Product Code CHL
  • Reason
    Qc bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mph.
  • Action
    The firm contacted their customers and informed them of this problem and provided a workaround procedure, in a a letter dated 1/12/2005. A ''Field Action Notification'' (FAN) was issued to the firm''s Field Service personnel on 1/21/2005. The letter instructs their personnel to update the NPT7 application software on all units to V3.05 and to hand over a copy of the letter ''Changes related to the Qualicheck2+ and NPT7,'' to the user/customers. In addition, the firm''s personnel were instructed to remove any of the suspect cartridges found on-hand at each customer location; destroy them;and replace them with different lot numberd product.

Device

Device Recall Dritek D7120, BGOX Cartridges Qualicheck2
  • Model / Serial
    Lot R0187, Expiration Date: Sept. 2005; and Lot R0016, Expiration Date: 08/2005.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled device component was distributed to a total of 56 customers, nationwide located in the following states: AL, AR, AZ, CA, CO, GA, ID, IL, KA, MA, ME, MI, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT & WA.
  • Product Description
    D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
  • Manufacturer
    Radiometer America Inc

Manufacturer

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