| TGA Action ID |
RC-2025-RN-00216-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ABL90 FLEX and ABL90 FLEX PLUS. An in vitro diagnostic medical device (IVD)
RWIN10 versions 1.0 (933-803) and 1.1 (933-894) on the E3815 CPU.
|
| ARTG Number |
228382 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
There is a potential risk with ABL90 FLEX and ABL90 FLEX PLUS analysers when operating with Radiometer Windows 10 versions (RWIN10 1.0 and 1.1). Specifically, the analyser software may unexpectedly "freeze" and restart during a sample measurement, causing the analyser to cease operation during the startup period.
If a restart occurs, any sample being processed at that time will be lost and treatment could be delayed. An unexpected analyser software restart could cause serious or life-threatening adverse health consequences. |
| Instructions for Customers/Users |
A local Radiometer representative will contact affected customers to discuss upgrading the analyser to software version RWIN10 1.2.
As a mitigation, customers are to ensure an alternative solution is available before using the analyser. This may include using an unaffected analyzer or sending the sample to a central laboratory.
This action has been finalised on 11/04/2025 |
| Action Commencement Date |
14/03/2025 |
| Responsible Entity |
|
| Contact Information |
1800 247 254 - Radiometer Pacific Pty Ltd |