Events

Recall of AutoCheck5

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
    78097
  • Event Risk Class
    Class 2
  • Event Number
    Z-3237-2017
  • Event Initiated Date
    2017-09-07
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158651
  • 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
    Controls for blood-gases, (assayed and unassayed) - Product Code JJS
  • Reason
    Radiometer has recently become aware that a few of the autocheck 5+ level 2 ampoules, will give incorrect results for pco2 and po2. a defective qc ampoule will for: " pco2 give a result close to or just outside of the low end of the control range. (4.92  5.85 kpa or 36.9  46.9 mmhg) " po2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kpa (104-107 mmhg).
  • Action
    Radiometer sent a Safety Notice dated September 7, 2017, to all affected customers. The firm initiated their recall on 09/07/2017 by email. The letter requested the following: 1. Please check your inventory and analyzers for any boxes and ampoules of above mentioned QC. 2. Discard all Boxes and ampoules of this lot. 3. Complete the response form and return it to the number on the form. Please note: If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-user. Customers with questions were advised to contact their Radiometer representative.

Device

AutoCheck5
  • Model / Serial
    S7745 Lot R0698
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland.
  • Product Description
    AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers || The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA