Events

Recall of D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). 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-Rad Laboratories 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-2013-RN-01258-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01258-1
  • 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
    The cartridge injection counts not being updated correctly when switching between the d-10 dual short program and extended program on the d-10 haemoglobin testing system due to the incorrect configuration setting in the update kit disk.
  • Action
    As an interim measure, users are advised to manually track the number of injections on the cartridge and monitor the QC results throughout the life of the reorder pack. Bio-Rad is replacing the affected disks with a new update disk to be used with affected Reorder Packs.

Device

D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). An in vitro diagnosti...
  • Model / Serial
    D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). An in vitro diagnostic medical device (IVD).Catalogue Number: 220-0201Reorder Pack Lot Numbers: 2003022, 20030337, 64000331, 64000332, 64000888, 64001344, 64002239, 64002240 and 64002241Floppy Diskette Lot Numbers: AA30324, AA30339, AA30545, AA31021 AA31023, AA31056, AA31097, AA31193, AA31194 and AA31195CD-ROM Lot Numbers: BA31021, BA31023, BA31056, BA31097, BA31193, BA31194 and BA31195
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd