Events

Recall of Device Recall Crea Calibration solution

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
    60929
  • Event Risk Class
    Class 2
  • Event Number
    Z-1008-2012
  • Event Initiated Date
    2011-12-16
  • Event Date Posted
    2012-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106824
  • 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
    Electrode, ion based, enzymatic, creatinine - Product Code CGL
  • Reason
    When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. this will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and results in a bias on the crea results.
  • Action
    Radiometer sent a Medical Device Recall letter dated December 28, 2011 to their customers. The letter provided details on the affected devices, description of the problem and actions to be taken. The firm instructed their customers to immediately examine their stock and return any remaining product to Raiometer America Inc. for disposal. The letter states that Radiometer will replace all bottles of the affected lots, at no charge. Customers were asked to complete the attached Recall Response Fax Form and fax to 800-736-0601. For questions regarding the Recall contact Radiometer America Technical support at 1-800-736-0600 opt. 4.

Device

Device Recall Crea Calibration solution
  • Model / Serial
    S1827 Part Number: 944-135, lot DV02
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: NY, PA and TN.
  • Product Description
    S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark || Product Usage: || The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA