Events

Recall of MIA FORA NGS HLA FLEX 11 KIT (24 tests). 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 Diagnostic Solutions 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-2017-RN-01491-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01491-1
  • 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
    Diagnostic solutions has been made aware by the manufacturer, bioarray solution, that a limited number of mia fora ngs hla flex 11 kit (24 tests) ce kits lot 18- 107-11-c contain index adaptor plates (iap) p/n sr-800-00349, lot 18-30a that may result in incorrect calls for samples in the f1 and g1 plate positions due to switched barcode adaptors in positions f1 and g1. the impact of a defective iap when used for testing will result in the wrong call at plate positions f1 and g1 and therefore an incorrect result.
  • Action
    Diagnostic Solutions is advising customers to quarantine all units of Lot 18-107-11-C from inventory. Diagnostic Solutions will confirm with users whether any of their stock is defective and will arrange for replacement of defective units. Diagnostic Solutions recommend that all F1 and G1 sample results generated with the MIA FORA NGS HLA FLEX 11 KIT (24 tests) Lot 18-107-11-C are retested to confirm samples have been correctly identified.

Device

MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD)
  • Model / Serial
    MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD) Lot Number: 18-107-11-CARTG Number: 288368
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd