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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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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

Product Detail

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