CentraLink Data Management Systems with software versions v13x, v14x, v15x. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2016-RN-01576-1

Class II

2016-12-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01576-1

This issue can only occur when the centralink data management system is connected to the advia workcell or advia labcell automation system and the laboratory information system (lis) does not include sampletype in work order downloaded to centralink. if the automated task to download samples to the laboratory automation system (las) processes immediately after the order is received from the lis, there is a remote possibility centralink may download an order to the advia automation system without specifying the sample type. on advia automation, the value “default” will be downloaded instead of the sample type and this may affect activities that are based on sample type, e.G. sorting for centrifugation based on sample designations. the activity may not be triggered if “default” is received.The risk to health due to this issue is remote given the timing required for the issue to occur and the need for an activity to fail such that an erroneously believable result occurs.

Siemens is recommending that the LIS specify the sample type in the work order, as the CentraLink system is designed to operate in an environment in which the sample type is specified in the work order that is downloaded from the LIS. A Siemens Technical Support Representative will contact laboratories to review their CentraLink configuration. If the LIS does not include sample type information in the sample orders downloaded to CentraLink and Pre-Tests assigned by sample type are configured on the ADVIA Automation System, the representative will update the configuration.