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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00999-1
Product Name/Description	LifeCycle for Prenatal Screening software Catalogue Number: 5014-0020 Version Number: v4.0 Rev4 ARTG Number: 216895
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/10/2015
Responsible Entity	PerkinElmer
Reason/Issue	The issue was caused by an unintended rounding of the median equation factors that led to inadequate number of significant digits (decimals) in the default median equation. The equation was originally introduced in LifeCycle version v4.0 Rev4. Due to the issue, the Inhibin A MoM level of an unaffected population was observed to be approximately half from what it should have been. This unintended rounding error was observed internally and no customer complaints have been received.
Recall Action	Recall for Product Correction
Recall Action Instructions	Perkin Elmer is providing users with instructions to correct the error. Alternatively, Perkin Elmer can implement the correction at the affected site. This action has been closed-out on 19/08/2016.
Contact Information	1800 033 391 - PerkinElmer