LifeCycle for Prenatal Screening v4.0, v4.0 Rev 2 and v4.0 Rev 3. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2015-RN-00452-1

Class II

2015-05-27

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00452-1

Wallac oy, a subsidiary of perkinelmer, has become aware that lifecycle for prenatal screening (5014-0020) may generate an incorrect risk calculation result for twins if lifecycle v4.0 risk calculation protocol is used and a particular sequence of actions occur.The issue is related to chorionicity correction of twins, which can be applied only with biomarker results for hcgb, papp-a and plgf in 1st trimester. if a second sample (e.G. 2nd trimester or dvpi examination) is attached to the same case, the moms should be cleared in order to recalculate the moms without chorionicity correction. if there are no gestational age calculation changes made, the 1st trimester sample moms will remain. since 1st trimester moms are chorionicity corrected when chorionicity is given, the mom values are too low resulting in unexpected risk values. if close to cut-off, a true risk value might end up on the opposite side of the cut-off and be reported as opposite risk result.

Customers are advised that if they are using the affected software version and follow the sequence of actions that will result in the above issue, they should ensure that the MoM’s for hCGb, PAPP-A and PlGF biomarkers are always cleared before recalculating the risk when a second sample is added to the same case. This can be achieved by clearing the chorionicity information and saving the case data. PerkinElmer has developed a Database Investigation Script that can be used to determine if any affected calculations exists in customer’s LifeCycle database. Any decisions regarding the need to reassess/recalculate previously reported risk value results should be made on a case by case basis. Software v4.0 Rev 4 is under development and will correct this issue. Customers will be notified when the software update is available and it will be provided to them free of charge. This action has been closed-out on 11/08/2016.