Events

Recall of CoaguChek HS Plus/Pro 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 Roche Diagnostics Australia Pty Limited.

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-01181-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-09-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01181-1
  • 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
    It has been identified that very occasionally, the coaguchek® xs plus meter or coaguchek® xs pro meter may power off when removed from the external power supply or handheld base unit if using the rechargeable handheld battery pack. due to a software error in the handheld battery pack the meter may sporadically go into an error mode, with the meter subsequently powering off. this issue affects only those battery packs in the range serial number uu100000 to uu109415 (batch number 05604041 to 05705151) with software revision 20 (please note: the revision number is printed on the outer package of the handheld battery pack; it is not visible on the battery pack itself). if this issue occurs, the battery pack should be removed and then reinserted to reboot the meter. the meter will then work correctly after reboot. alternatively, if not connected to the lis, the meter may be used with 4 aa batteries and the standard battery compartment cover.
  • Action
    1. If this issue occurs, the battery pack should be removed and then reinserted to reboot the meter. The meter will then work correctly after reboot. Alternatively, if not connected to the LIS, the meter may be used with 4 AA batteries and the standard battery compartment cover. 2. Contact Roche Diagnostics Australia via the call centre on 1800 645 619 to arrange for a replacement battery pack, quoting the reference number QN-CPS-2017-174. 3. Retain this letter in a prominent place in your laboratory for at least one month. 4. Acknowledge receipt of the notification, using the supplied link or reply directly to Roche Diagnostics Australia by email at australia.qra@roche.com to confirm your receipt of this notification.

Device

CoaguChek HS Plus/Pro System. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    CoaguChek HS Plus/Pro System. An in vitro diagnostic medical device (IVD)CoaguChek XS Plus systemMaterial Number: 04800842190CoaguChek XS Pro systemMaterial Number: 05530199190Handheld battery packMaterial Number: 04805640001Serial Number / BatchesSerial Number range: UU100000 to UU109415Batch Numbers: 05604041 to 05705151ARTG Number 197926
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited