Print version of this report
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 Inverness Medical Innovations Australia Pty Ltd
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