| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00414-1 |
| Product Name/Description |
enGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) v8.06
Product Code: 6802883
Lot Numbers: enGen Select Versions 3.2.2 and below & enGen Custom versions 3.2.2 and below |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
The enGen Laboratory Automation System is an automated track which integrates clinical analysers and the customer’s LIS (Laboratory Information System). It centrally controls pre-analytical and post-analytical processing as well as sample transport to multiple independent analysers and devices. Ortho Clinical Diagnostics (OCD) internal testing has determined that when a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Laboratories are advised to manually rerun samples that have been prematurely stored. A software modification is currently in development and will be provided once complete. This action has been closed-out on 11/02/2016. |
| Contact Information |
1800 032 859 - Ortho-Clinical Diagnostics Customer Technical Services |