| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00843-1 |
| Product Name/Description |
LifeCycle for Prenatal Screening software. An in vitro diagnostic medical device (IVD).
Catalogue numbers: 5002-0020
Software version: v2.1, v2.2, v3.0, v3.1, v3.2 (including all revisions) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has become aware of an unexpected behaviour in how the LifeCycle risk calculation engine (Elipse) accepts and utilizes the Ethnic Factor given by the user. If the Ethnic Factor has been changed from a valid numeric value to "0" (zero) the case risk will not be calculated by applying the latest validated median equation as intended by the user. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
PerkinElmer is advising users to replace the default median equations supplied at installation with laboratory-specific ones and maintain the Marker Medians-form to ensure the Ethnic Factor values are greater than zero. PerkinElmer are recommending users update the software to version 4.0 rev 2. A review of past results should be made on a case by case bases as recommended by PerkinElmer. |
| Contact Information |
03 9212 8516 - Perkin Elmer Software Services |