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CRYOcheck Factor VIII Deficient Plasma with VWF

Precision Biologic Inc · Model FDP08VWF · UDI-DI 00843876000589

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Description

CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% sodium citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying Factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use. CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and which contains normal levels of von Willebrand Factor (VWF), buffered with HEPES. Factor VIII has been assayed at less than 1% of normal antigen and activity levels while VWF antigen and activity levels are >50%. Device is provided frozen as 25 vials of 1.0 mL

Recalls

Date	Firm	Reason
2015-05-11	Siemens Healthcare Diagnostics, Inc.	Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range.
2013-01-28	Diagnostica Stago, Inc.	Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
2005-07-08	Dade Behring , Inc.	sample may exhibit falsely high results

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.