therascreen PyroMark Gold Q24 Reagents and Pyro Buffers. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2018-RN-00069-1

Class II

2018-01-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00069-1

Qiagen have identified an increased number of cases with altered ratios in the pyrogram peak patterns for therascreen pyrosequencing assays. use of the affected lots is associated with an elevated invalidity and re-testing rate.In addition, use of the affected lots also creates an elevated risk of a59t false positive results for the pyrosequencing analysis of nras codon 59 with the therascreen ras extension pyro kit (ref 971590).In pyrosequencing runs performed with the affected material, the ratio of the peak height for datp peaks in pyrograms is artificially increased while in parallel the peak height for dgtp may be decreased. this may result in an altered ratio of peak heights and consequently leads to an incorrect determination of allele mutation frequencies.

Qiagen is advising users to discontinue use of the affected lots and contact Qiagen for replacement lots. Please ensure the corresponding assay Plug-in reports for automated result interpretation are used. If users have used the affected lots, it is strongly recommend a review of the corresponding results.