| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00633-1 |
| Product Name/Description |
ACL Top Family of instruments (haemostasis testing systems). An in vitro diagnostic medical device (IVD).
ACL TOP
Part Number: 00000280000
ACL TOP CTS
Part Number: 00000280020
ACL TOP 700
Part Number: 00000280010
ACL TOP 700 CTS
Part Number: 00000280050
ACL TOP 700 LAS
Part Number: 00000280030
ACL TOP 500 CTS
Part Number: 00000280040
ACL TOP 300 CTS
Part Number: 00000280060 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
There is potential for a sample misidentification on the ACL TOP Family that only occurs following a specific set of steps combined with the inability of the system to read a specific sample rack barcode. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Werfen Australia is providing work around instructions to follow to mitigate the issue. A software update to correct the issue is in development and will be implemented once completed. This action has been closed-out on 11/02/2016. |
| Contact Information |
1300 369 132 - Werfen Australia |