Multiplate Analyser. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00734-1

Class II

2017-06-14

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00734-1

Roche identified that specific multiplate stirrer boards (replaced by another type 7.5 years ago) may develop an increasing stirring speed above specification. all channels are affected in the same way. too high stirrer speed may correlate with a falsely decreased recovery and therefore may lead to falsely low patient results. investigation has showed in maximum a reduced recovery of 80% (= bias -20%) and that the degree of decreased recovery depends on assay, with adp, trap, aspi more affected than col. although no testing was performed for the ristotest and adptest hs, similar low recovery of platelet function test results is assumed for these tests. in case of falsely low patient results due to falsely decreased recovery of platelet function tests (adptest, aspitest, traptest, coltest, ristotest adp hs test) the platelet function in diagnostic measures may be incorrectly interpreted as impaired.

A Haemoview Diagnostics representative will schedule the necessary repair measures with the user. Until then, the affected Multiplate Analyser must not be used for diagnostic purposes. A loan device will be provided.