Corrective Action for Coagulation Factor IX Deficient Plasma, Dade Behring
2008.02.11
Product group In-vitro diagnostics
Reference 00297/08
Corrective Action of Dade Behring (Siemens Healthcare Diagnostics) for Coagulation Factor IX Deficient Plasma (OTXX) (lot number 500829 and lower) with Dade Actin FSL Activated PTT Reagent (B4219) on BCS® and BCS® XP Systems because the on-board stability of reconstituted Coagulation Factor IX Deficient Plasma is less than manufacturer claims in the instrument reference guides. The customers were informed about the problem and how to avoid it.