| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00994-1 |
| Product Name/Description |
942-073, D8088_Crea A, D8089_Crea B Membranes used on the ABL827 blood gas analyser. An in vitro diagnostic medical device (IVD)
Lot Number: R0530 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
15/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer Medical has become aware that Lot R0530 of 942-073, D8088-Crea A,D8089-Crea B, membrane box for E8088 and E8089 electrodes has been packed in error with capsules of electrolyte solutions for Glucose/Lactate electrodes. Testing by the manufacturer has established that the incorrect capsules of electrolyte solutions do not influence the performance of the Crea results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Radiometer is requesting their customers to discard remaining units from the affected lots. Alternative units are available. This action has been closed-out on 01/03/2016. |
| Contact Information |
1800 247 254 - Radiometer Pacific |