Events

Recall of MIA FORA NGS FLEX 11 HLA Typing Kit. 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 Abacus dx 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-2018-RN-00507-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-05-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00507-1
  • 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
    Abacus have been notified by the manufacturer, bioarray solutions, that lot # 18-299-11-c contains a subassembly kit (mia fora ngs flex hla pcr kit 2 (lot 18-299)) with an incorrect expiration date of 2109-04-30 instead of 2019-04-30. no other subassemblies within lot 18-299-11-c are impacted and no other mia fora ngs flex 11 hla typing kit lot numbers are affected.
  • Action
    Abacus is requesting users to identify impacted product and correct the PCR kit 2 expiry date to 2019.

Device

MIA FORA NGS FLEX 11 HLA Typing Kit. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    MIA FORA NGS FLEX 11 HLA Typing Kit. An in vitro diagnostic medical device (IVD). Product Number:TL-SR-800-10433-24Lot Number: 18-299-11-C ARTG Number: 288368Abacus dx - Multiple human leukocyte antigens (HLA) typing IVDs
  • Manufacturer
    Abacus dx Pty Ltd

Manufacturer

Abacus dx Pty Ltd