Exacto Pro test and others 에 대한 현장 안전성 서한

Field Safety Notice

2016-06-08

Slovenia

AMPMDRS

We would like to inform you about the suspension of the placing on the market, of the use and of the withdrawal of the in vitro medical devices exacto pro test hiv ref 857318, biosynex hivtop ref 1150004, hivtop ref 5059, immunoquick hiv ref 0556_k25, biosynex hcv ref 1150002, hcvtop ref 5058, immunoquick hcv ref 0557_k25, biosynex hbv ref 1150003, hbvtop ref 5060, immunoquick hbsag ref 0558_k25. this decision follows an inspection at biosynex from the ansm (agence nationale de sécurité du médicament et des produits de santé), our french health authority. this inspection was due to the fact that the who highlighted negligence and non- compliance at one of our subcontractor’s facilities. based on the negligence and non-compliance observed by the who and the ansm, biosynex has decided to suspend the manufacturing, the commercialization and the use of these devices. we will also withdraw and recall all the tests until they comply again with the applicable regulations.