ACL Top Family of analysers used with HemosIL APTT reagent (an in vitro diagnostic medical device (IVD)) 의 리콜

Recall

RC-2013-RN-00774-1

Class II

2013-07-31

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00774-1

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.

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.