Events

Recall of LABType DNA Typing Tests (for transplant compatibility analysis). 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 Bio-Strategy 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-2016-RN-01380-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01380-1
  • 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
    Lot specific user documents and catalog files updated for the january 2016 nomenclature contain incorrect allele specificity information for certain beads for particular labtype dna typing tests. the affected documents and catalog files were accessible between the date period july 29, 2016 to august 22, 2016.
  • Action
    Bio-Strategy has provided customers with corrected lot-specific user documents and catalog files, and advised that results obtained using the affected products and incorrect user documents and catalog files should be reviewed using the corrected information. This action has been closed-out on 17/05/2017.

Device

LABType DNA Typing Tests (for transplant compatibility analysis). An in vitro diagnostic medical ...
  • Model / Serial
    LABType DNA Typing Tests (for transplant compatibility analysis). An in vitro diagnostic medical device (IVD).SSO Class II DRB1 (Catalog ID: RSSO2B1, RS02B1T)HD Class II DRB1 (ID: RSSOH2B1, RSOH2B1T, RSSOH2B1X)SSO Class II DQA1/DQB1 (ID: RSSO2Q, RSSO2QX, RSO2QT)SSO MICA (ID: RSSOMICA)SSO Class I Bw4 Supplement (ID: RSSO1S4, RSO1S4T)XR Class II DRB1 (ID: RSSOX2B1, RSOX2B1T)CWD Class II DRB1 (ID: RSSOW2B1, RSOW2B1T)Multiple lots affected.ARTG Numbers: 236737 & 236738
  • Manufacturer
    Bio-Strategy Pty Ltd

Manufacturer

Bio-Strategy Pty Ltd