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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00774-1
Product Name/Description ACL Top Family of analysers used with HemosIL APTT reagent (an in vitro diagnostic medical device (IVD))

Models affected: ACL TOP, ACL TOP CTS, ACL TOP 700, ACl TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS and ACL TOP 300 CTS

Part Numbers: 00000280000, 00000280010, 00000280020, 00000280030, 00000280040, 00000280050 and 00000280060

ARTG Number: 197892, 98770
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 31/07/2013
Responsible Entity Werfen Australia Pty Ltd
Reason/Issue Werfen Australia's investigation of recent customer complaints determined that an ACL TOP Family instrument can experience carry-over that causes shortened APTT clotting times on patient and/or quality control results. Carry-over can occur when a HemosIL SynthaASil APTT reagent (PN 0020006800) is located in the same reagent rack as certain other HemosIL reagents. The carry-over is introduced during the liquid height check that is performed upon rack insertion and is dependent on material position, the order of rack insertion, and the sequence in which the assays are performed.
Recall Action Recall for Product Correction
Recall Action Instructions Werfen is providing users with work around instructions to follow to mitigate the potential for this issue to occur. The requirement for a look back at previously reported results should be determined by the laboratory director. A software update is currently under development to correct this issue permanently. This action has been closed-out on 10/02/2016.
Contact Information 1300 369 132 - Werfen Australia