Z-2154-2012 Class II Terminated

Recalled by Greiner Bio-One North America, Inc. — Monroe, NC

Recall Details

Product Type
Devices
Report Date
August 15, 2012
Initiation Date
July 2, 2012
Termination Date
June 11, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
838.9 cases (1,006,700 pieces)

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.

Reason for Recall

Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.

Distribution Pattern

Nationwide Distribution

Code Information

Lot #B041206