Print version of this report
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 Werfen Australia Pty Ltd
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