| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00599-1 |
| Product Name/Description |
VITROS XT Chemistry Products ALB-TP Slides. An in vitro diagnostic medical device (IVD).
Product Code: 684 4293 (10758750031771)
All lots
ARTG 232248
(Ortho-Clinical Diagnostics Australia Pty Ltd - Clinical chemistry substrate IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
VITROS XT Chemistry Products ALB-TP Slides may create dust and debris within the MicroSlide Subsystem on VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems. Dust and debris from XT ALB-TP Slides may impact VITROS Chemistry Products Na+ Slides leading to a potential increase in non-reproducible, positively, or negatively biased Na+ results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
• Perform a thorough cleaning of the MicroSlide Subsystem on their VITROS XT 3400 and/or VITROS XT 7600 System(s). Appendix 1: VITROS XT System Cleaning Focus, which is included with the customer letter, contains a list of specific areas which have been observed to accumulate dust and debris shed from VITROS XT ALB-TP Slides.
• Prepare any crossover procedures which may be required as part of their laboratory’s transition from using VITROS XT ALB-TP Slides to the VITROS Chemistry Products ALB Slides and VITROS TP Slides products.
• Upon receipt of replacement VITROS Chemistry Products ALB Slides and TP Slides products and completing any required crossover procedure, discontinue using, render unusable, and discard any remaining inventory of VITROS XT ALB-TP Slides. |
| Contact Information |
1800 032 359 - Technical Services Centre |