03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [Product Description] 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes. [Code Info] Lot #B041206 [Reason for Recall] Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests. [Recalling Firm] Greiner Bio-One North America, Inc. [Classification] 
Class II
C l a s s I I
C l a s s I I I
C l a s s I
Enforcement Report - Week of August 15, 2012