| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01108-1 |
| Product Name/Description |
Lactate membrane for ABL700 series and ABL800 series blood gas analysers (Part 942-066, D7077) . An in vitro diagnostic medical device (IVD)
All lot numbers affected
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Potential enzyme residue on the outside of a newly replaced Lactate membrane may cause an initial negative bias on the reported Lactate result. If this residue exists the bias will decrease over the in-use time. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer is providing work around instructions to mitigate the issue and are currently reviewing the manufacturing process to implement changes that will prevent the possibility of this occurrence |
| Contact Information |
1800 247 254 - Radiometer Pacific |