| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00714-1 |
| Product Name/Description |
Radiometer ABL90 Series analysers with software version 3.2 or below. An in vitro diagnostic medical device (IVD)
All Serial Numbers
ARTG Number: 228382 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
In August 2015 Radiometer advised users about a potential issue (TGA Ref. RC-2015-RN-00805-1) where a battery module overheated caused by the continued charging of a failing battery cell. The temporary countermeasure recommended, after the battery modules below 910-311P0009Nxxx had been replaced, was for the capacity of the battery module to be checked at least every 12 months following the instructions that were provided.
The manufacturer has now released an upgrade of the ABL90 series software to software version 3.3 or higher. This new version monitors the charge level for the battery. If one or more failing battery cells are detected, the analyser status turns yellow and message 1559 “Battery error detected” appears. If message 1559 has been active for four weeks in a row, the analyser enters Operator Intervention Required with message 1560 “Battery error still detected” and the analyser is locked until the battery has either been removed or exchanged. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer will contact users to arrange for the installation of the software upgrade.
This action has been closed out on 30/10/2019 |
| Contact Information |
1800 247 254 - Radiometer Pacific |