| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00773-1 |
| Product Name/Description |
VITROS Chemistry Products MicroSlides (an in vitro diagnostic medical device (IVD))
Multiple catalogue numbers affected
Expiry dates to 22 March, 2015
ARTG Number: 25922 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
The VITROS MicroSlide Cartridge is made up of the cartridge body and an Anti-Backup Platen (ABP). The purpose of the ABP is to keep the stacks of slides in the correct position for dispensing. Ortho Clinical Diagnostics have received reports associated with ABP failing to advance, jamming or failing to stay locked in place within the cartridge. When this occurs, the slide is not properly dispensed from the cartridge since the stack of slides is not positioned correctly. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho Clinical is providing users with work around instructions to resolve slide dispense issues. Users are advised to replace the affected unit and contact Ortho Clinical for a replacement if they are unable to resolve a slide dispense issue by repositioning the ABP. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 032 359 - Customer Technical Support |