| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01201-1 |
| Product Name/Description |
cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range
Item Number: 942-073
ARTG Number: 229300 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
RADIOMETER has become aware that the cCrea results for QC decreases to below the lower acceptance limit within the lifetime of the Crea membranes. This has been experienced on membranes down to five days after installation of new membrane units. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer is advising their customers to perform one quality control measurement using S7835 AutoCheck 6+, level 1 (Item 944-094), on already installed Crea membrane units to verify the cCrea performance. If the QC result is out of range, please install new Crea A and Crea B membranes.
Until further notice the following must be carried out every 24 hours:
- Perform one quality control measurement using S7835 AutoCheck 6+, level 1 (944-094) to verify the cCrea performance.
- If the QC result is out of range, new Crea A and Crea B membranes must be installed. This action has been closed-out on 05/08/2016. |
| Contact Information |
1800 247 254 - Radiometer Pacific |