| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00726-1 |
| Product Name/Description |
D788 pCO2 Membrane (catalogue number 942-063) used with Radiometer ABL700 and ABL800 series analysers (An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer Medical has become aware that some pCO2 membranes can cause a negative bias, on both blood and quality control measurement results.
The bias can be seen after the replacement of the membrane. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer Medical are providing additional quality control instructions to ensure the accuracy of pCO2 results. This action has been closed-out on 10/02/2016. |
| Contact Information |
1800 247 254 - Radiometer Pacific |