ADVIA Centaur XPT System, with software versions V1.0.1, V1.0.2 and V1.0.3 의 리콜

Recall

RC-2015-RN-01205-1

Class II

2015-12-09

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01205-1

Siemens healthcare diagnostics has identified a number of issues that may affect the operation and workflow of the system.A summary of the issues is listed below. however this is not a comprehensive list. please refer to the customer letter for the full details.- if the assay is being run with multiple replicates defines, the analyser reports the results as a mean for all replicate results. this may lead to incorrect diagnosis. if the final result rule is disabled, it may lead to delayed diagnosis of hepatitis c viral infection or hiv. if the manual final result rule is being used with multiple replicates, it may lead to a missed diagnosis of toxoplasmosis. if you are running samples with replicates set to any value greater than 1, siemens recommends a look back of all results that may be affected.- if there is a unit change in test definition for assay & the delta check functionality is enabled, it may lead to incorrect flagging.

Siemens is advising users that a number the issues may be corrected with software upgrade V1.1. The remaining issues will be corrected in a future software update, and Siemens is providing work around instructions as a interim measure. Siemens is recommends a lookback of patient results if users are running samples with replicates greater than 1 and discussing the customer letter with the Laboratory Director.