| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00762-3 |
| Product Name/Description |
Afinion AS100 Analyser, CRP and CRP Control; An in vitro diagnostic medical device (IVD)
Afinion AS100 Analyser
REF: 1115027, 1115173, 1115174, 1115176, 1115172, 1115175, 1115507, 1115419 & 1115516
Afinion CRP
REF: 1115013, 1115014 & 1115377
Afinion CRP Control
REF: 1114993
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
1) Axis-Shield PoC AS, the manufacturer of Afinion CRP system, warns that an information code (error code) which is displayed on the Analyser screen might potentially be misinterpreted as a high CRP result.
2) The CRP concentration in frequently opened control vials may increase due to evaporation. Therefore, the stability of opened vials of Afinion CRP Control has been reduced from 8 to 4 weeks. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Alere is providing work around instructions and will be implementing a software update. |
| Contact Information |
07 3363 7711 - Alere Technical Support |