| TGA Action ID |
RC-2025-RN-00335-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CELL-DYN Ruby. An in vitro diagnostic medical device (IVD
Serial number: 70418BG |
| ARTG Number |
199356 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
When expired reagents are scanned or manually entered on the CELL-DYN Ruby haematology analyser, the system changes the expiration date to current or future date. This change occurs without notifying the user that an expired reagent is inadvertently being used.
There have been no reports of impact to patient management. |
| Instructions for Customers/Users |
The CELL-DYN Ruby Operator’s Manual will be updated to provide information regarding this problem.
Customers are to:
- always use reagents within their valid expiration dates for all testing procedures.
- confirm the container labelling matches the data on the reagent log entry screen dialog box.
- familiarise with the updated Operator’s Manual regarding this problem. |
| Action Commencement Date |
24/03/2025 |
| Responsible Entity |
|
| Contact Information |
1800 816 696 - Abbott Customer Service |