Dimension Vista 500/ Dimension Vista 1500 Intelligent Lab Systems, software versions V. 3.6.1 SP1 or V. 3.6.2. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00368-1

Class II

2016-03-30

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00368-1

Siemens healthcare diagnostics has received customer complaints of discrepant patient results on dimension vista intelligent lab systems. siemens healthcare diagnostics has identified a software defect which, in a very specific set of circumstances, results in the dimension vista system omitting an aliquot probe rinse between sample aspirations when processing tubes in sample racks that are front loaded on the dimension vista system. omission of the aliquot probe rinse may result in carryover of residual sample estimated up to 10% when the sample is dispensed into the aliquot well. carryover of residual sample from the outside of the aliquot probe into the sample tube is estimated at less than 0.1%.Although unlikely, the potential for erroneous results due to sample carryover may lead to result misinterpretation.

Siemens has developed a software update which will address the reported issue. The update will be installed on all affected units. Until the affected software version is updated, users are advised to follow the specific instructions provided under “Actions to be Taken by the Customer” in the customer letter.