| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01181-1 |
| Product Name/Description |
CoaguChek HS Plus/Pro System. An in vitro diagnostic medical device (IVD)
CoaguChek XS Plus system
Material Number: 04800842190
CoaguChek XS Pro system
Material Number: 05530199190
Handheld battery pack
Material Number: 04805640001
Serial Number / Batches
Serial Number range: UU100000 to UU109415
Batch Numbers: 05604041 to 05705151
ARTG Number 197926 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
13/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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.
This action has been closed out on 15/10/2018 |
| Contact Information |
1800 645 619 - Roche Diagnostics Call Centre |