Alere Afinion CRP for C-reactive protein testing in primary care

Regulatory information

The Alere Afinion CRP test was CE-marked as an in vitro diagnostic medical device in May 2005.

A search of the Medicines and Healthcare Products Regulatory Agency website revealed 1 manufacturer field safety notice (July 2016) for this technology. Two specific lots have been identified that give an increased frequency of error codes when stored at room temperature. There are no indications that other lots are affected. The affected kits will be replaced by Alere and the replacement kits must be stored refrigerated between 2°C and 8°C only.