ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - BNP Ready Pack Lot 038174 (An in vitro diagnostic medical device (IVD)) 의 리콜

Recall

RC-2014-RN-01080-1

Class II

2014-10-08

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01080-1

Siemens healthcare diagnostics has confirmed that there may be an incorrect side label on a small percentage of the advia centaur systems bnp ready packs from reagent lot 038174. incorrectly labelled ready packs are included within kit lots 43305174, 43278174, 43306174 and 43279174. the human-readable side label may incorrectly identify the ready pack as advia centaur systems ft4 ready pack. the ready pack end label and the barcode end label correctly identify the ready pack as the advia centaur systems bnp ready pack and the ready pack will scan correctly as bnp when loaded onto the advia centaur systems. the kit boxes are correctly labelled as bnp. other advia centaur bnp kit lots ending in 174 are not impacted. the reagent in the ready pack has been verified as bnp reagent and will generate valid results when calibrating and running quality control or patient samples using the affected advia centaur systems bnp ready pack kit lots.

Siemens Healthcare Diagnostics(SHD) is instructing their customers to examine their inventory of BNP Ready Packs identified with the human-readable FT4 side labels and discard any affected packs. Siemens representative will provide the product replacement. Siemens is also informing their customers that any results generated with an affected pack are valid; the instruments identify the pack correctly and there is no performance issue with the reagent within the packs. This action has been closed-out on 11/08/2016.