| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00328-1 |
| Product Name/Description |
enGen Laboratory Automation Systems, An in vitro diagnostic medical device (IVD)
Affected Versions: Systems configured with enGen Select v5.0 and Custom or Select v3.2.2 and below
Product Code: ENGEN |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics (OCD) is advising users of a software anomaly regarding the routing of urine samples which required pre-treatment for assays using VITROS Chemistry Products Ca, Mg and PHOS Slides. The enGen System software currently does not route samples which require acidification pre-treatment to the Manual High Priority exit location for pre-treatments as intended. In addition, the enGen System software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pre-treatment.
OCD internal testing has confirmed instances where VITROS 5,1 FS, 4600 or 5600 Systems allowed testing of multiple assays using a single urine specimen, regardless of the pre-treatment requirements for each selected assay, potentially leading to biased patient results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
OCD is providing temporary work around instructions for users to prevent the failure mode. A software update will be implemented as a permanent fix. Also, OCD is advising users to discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 11/08/2016. |
| Contact Information |
1800 032 359 - Ortho Clinical Diagnostics Customer Technical Services |