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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Product Detail

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.
Recall Number Z-2154-2012
Classification Class II
Code Info Lot #B041206
Product Distributed Qty 838.9 cases (1,006,700 pieces)
Reason For Recall Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.

Event Detail

Event Id 62595
Product Type Devices
Status Ongoing
Recalling Firm Greiner Bio-One North America, Inc.
City Monroe
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution