| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00137-1 |
| Product Name/Description |
Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic medical device (IVD).
All Serial Numbers connected to HIS/LIS or middleware Data Management system
ARTG Number: 228382 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
On the ABL800 series analysers, the sample type “cord blood” has been changed into the two sample types “cord blood arterial” and “cord blood venous". This change took place with software version 3.1 MR5. Despite the selected sample type being correctly displayed on the ABL800 series analyser itself, the analyser will transmit the less specific sample type "cord blood" to a HIS/LIS or middleware system. The described error may in a worst-case scenario lead to minor foetal hypoxic stress not being immediately recognised if the clinician was to use data from the HIS/LIS or middleware system to determine treatment. This may cause a minor delay of necessary treatment of the newborn infant. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer is advising operators and clinicians using the "cord blood" sample results from a HIS/LIS or a middleware system to determine treatment to be aware that "arterial" or “venous" is not transmitted from the Analysers. Users are further advised that they will be notified when the new software fix is available for installation.
This action has been closed out on 16/04/2020 |
| Contact Information |
1800 247 254 - Radiometer |