ADVIA Centaur & ADVIA Centaur XP Immunoassay System (An in vitro diagnostic medical device (IVD)) 의 리콜

Recall

RC-2014-RN-00910-1

Class I

2014-08-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00910-1

Siemens healthcare diagnostics is conducting an urgent recall for product correction for the advia centaur and advia centaur xp immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the advia centaur and advia centaur xp immunoassay systems. pushing the sample racks may cause misreads of sample ids (sid) if the sample rack loading instructions are not followed exactly as described in the advia centaur or advia centaur xp operator’s guide.If a sample rack is manually pushed with a slight forward nudge to the entry position without placing it on the rack positioning guide, the barcoded tube sid can be assigned to different positions in the rack. this may lead to misreported results.

Siemens Healthcare Diagnostics is advising the customers that when loading a sample rack, the user must ensure that the sample rack notch rests on the raised area of the sample entry queue and the system automatically moves the rack to the loading position. The raised guide ensures the sample rack is positioned correctly and will accurately scan each barcode as it enters the inprocess queue. Users are further advised not to push the sample racks into the system. During the next service visit, Siemens Healthcare Diagnostics service engineers will affix a label stating "Do not push sample rack" onto the system to reinforce the proper loading technique of the sample rack. This action has been closed-out on 5/08/2016.