Medical device manufacturer, Abbott Molecular Inc., has issued a medical device safety alert concerning its RealTime High Risk HPV Assay and RealTime High Risk (HR) HPV m2000 system ROW Combined Application CD-ROM [List no.: 02N09 and 4N05-01; Version 1.0 of the RealTime High Risk (HR) HPV m2000 system ROW Combined Application CD-ROM]
According to the manufacturer, m2000rt instrument noise is defined as an unexpected cycle-to-cycle variability in the fluorescence signals during the amplification and detection process. The manufacturer has identified that the instrument noise lower limit validity parameter for the RealTime HR HPV assay is set outside of the optimal setting to flag excess variability in fluorescence signal. Therefore, in the presence of excess noise, incorrect results could be generated.
It is normal for instruments to have some variability in fluorescence signal (noise). However, one factor that could contribute to excess instrument noise is m2000rt lamp issues. A resolution has been identified and requires a change to the instrument noise validity parameter for RealTime HR HPV Assay.
The manufacturer will correct the issue in the next version of the assay software. Affected users are recommended to follow the technical solutions mentioned in the Field Safety Notice until an upgrade to the new software can be installed.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 02 December 2013