| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01128-1 |
| Product Name/Description |
ABL90 FLEX Analyser. An in vitro diagnostic medical device (IVD)
(blood gas analyser)
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
RADIOMETER has recently become aware of a potential issue of negative bias on Sodium results if the ABL90 is not on a horizontal table. When tilted by 10 degrees or more and idle for 30 -45 minutes the magnitude of the effect on sodium results is as large as 10 mM (7%) in the worst case. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer is advising users to ensure that the ABL90 is placed on a horizontal platform/table. If the analyser is on a roll stand users must ensure that the support plate is aligned horizontally and locked in position. Radiometer will perform alignment of roll stands on request. A detection mechanism will be provided in an upgraded version of the analyser software to eliminate the possibility of error. |
| Contact Information |
1800 247 254 - Radiometer Pacific |