Field Safety Notice: Beckman Coulter, Access BR Monitor

donderdag 4 mei 2017 17:00

Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de sécurité du Medicament et des produits de santé (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).