| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00125-1 |
| Product Name/Description |
LifeCycle for Prenatal Screening, software versions V3.0, v3.1, v3.2, v4.0. An in vitro diagnostic medical device (IVD)
Catalogue Numbers: 5002-0020, 5014-0020
|
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has become aware that LifeCycle for Prenatal Screening may generate an incorrect risk calculation with IVF (in vitro fertilisation) screening cases. The problem occurs if the user enters data incorrectly in combination with a specific series of events as described below:
· The user initially enters the mother’s birth date (DOB) incorrectly for an IVF case, and calculates the risk using the incorrect DOB
· The user recognises the DOB entry error, corrects the error by entering the correct DOB and recalculates the risk
· LifeCycle does not utilise the corrected DOB, and recalculates the risk using the initial, incorrect DOB
· LifeCycle generates an incorrect risk calculation for the IVF screening case |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The LifeCycle issue can be corrected by either upgrading to LifeCycle software version v4.0 Rev2, or by implementing dedicated software Service Pack (LifeCycle Service Pack 12-03c) to resolve the problem. End users are recommended to choose one of the two options and the software upgrade will be provided free of charge. |
| Contact Information |
03 9212 8516 - PerkinElmer |