| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01163-1 |
| Product Name/Description |
ACL ELITE, ACL ELITE PRO, ACL 8000, ACL 9000 and ACL 10000 (coagulation analysers) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Sporadically lowered APTT results outside of the CLIA allowable error limit of 15% when using these IL locked Test Groups.
Please note that this Recall for Product Correction was originally initiated by Beckman Coulter in December 2011. The product and recall action was taken over by Werfen Australia in 2012. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
|
| Contact Information |
02 9098 0200 - Werfen Australia |