Events

Recall of Access Immunoassay Systems Access Folate Calibrators, An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

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
    RC-2012-RN-00780-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00780-3
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Beckman coulter has confirmed that the stability, while frozen, for the access folate calibrators may produce falsely elevated results which could mask a folate deficiency. product number a14207 may experience this issue at 12 months, and product number a98033 at 6 months.
  • Action
    Discontinue and discard remaining inventory. Review the historical quality control data and confirm Access Folate assay performance when using the affected lots in within the laboratory specifications.

Device

Access Immunoassay Systems Access Folate Calibrators, An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Access Immunoassay Systems Access Folate Calibrators, Part numbers: A14207, A98033. An in vitro diagnostic medical device (IVD)Part Number: A14207Lot Numbers: 112788 (Expiry Date 30 JUN 2012); 115741 (31 AUG 2012); 118917 (31 OCT 2012)Part Number: A98033Lot Numbers: 122651 (31 JUL 2012); 123635 (30 SEP 2012); 219962 (31 OCT 2012)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd