IMMULITE Systems 1000 / 2000 / 2000 XPi CMV IgM Assay (used for the determination of Cytomegalovirus (CMV)). An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-01164-1

Class II

2016-09-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01164-1

Siemens healthcare diagnostics has identified increased imprecision on some patient samples with the affected cmv igm reagent lots identified on the immulite / immulite 1000 and the immulite 2000 / immulite 2000 xpi systems. these samples may exhibit higher percent coefficient of variation (% cv) than the precision performance data published in the instructions for use (ifu) across nonreactive, indeterminate, and reactive ratios. quality controls provided in the cmv igm kit may not detect the imprecision with patient results. siemens is continuing to investigate the cause of the imprecision. the risk to health is remote and limited to a falsely nonreactive result when truly indeterminate or reactive, which may lead to delayed investigation of acute cmv infection.

Siemens is advising users to discontinue use and discard the affected batches, and recommends transitioning to IMMULITE/IMMULITE 1000 kit lot 0332 and above and IMMULITE 2000/2000 XPi CMV IgM kit lots 268 and above. Siemens is recommending a look back, including retesting of existing samples provided specimens meet time and storage conditions specified in the Instructions for Use, for previously generated nonreactive results of =0.40 and <0.9. Retesting using CMV IgM or another appropriate CMV test, depending on the clinical context and timing of the initial test, may be considered.