Various Microgenics Application Sheets. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00692-1

Class II

2017-06-14

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00692-1

During an internal assessment, thermo fisher scientific found that application sheets provided by the manufacturer microgenics for expanded use of some assays are inadequate. specifically, the appropriate validation data for the expanded use of these assays, as indicated in the instructions for use (ifu) when not used on manufacturer approved analysers, is inadequate. in addition, microgenics did not clearly state in these application sheets that the parameters provided are only to be used as starting points and that each assay setting needs to be validated individually by the user.Thus the information given on the specific application sheets for use with non-microgenics approved analysers may be ineffective. it is possible that assays not validated for use with other instrument platforms could potentially lead to erroneously low or high test results.

Thermo Fisher Scientific is requesting users to 1) immediately discontinue use of the affected application sheets used on their specific instrument platform, 2) review their internal assay validations to determine if their current instrument settings using these assays require additional action within their clinical laboratory settings (consult a qualified healthcare professional, as appropriate) and 3) contact Customer Service to check if additional action is required.