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.
FDA Recall Z-2154-2012 · Posted 2012-08-07
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Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeGIM
Date Initiated2012-07-02
Date Terminated2013-06-11
Product Quantity838.9 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.
Firm Action
Distributors were notified by letter on 07/02/2012 and customers were sent a letter dated 07/05/2012. The letters identified the affected product and the reason for the recall. Distributors were asked to stop distributing the affected product and to complete the attached Product Disposition form. The form along with the affected product was to be returned to GBO. The firm will provide replacement stock or issue a credit once product return and receipt of the Product Disposition form has been confirmed. Customers were also asked to complete the Product Disposition Site Confirmation form and fax it back to Greiner Bio-One North America, Inc. at the number provided. The letter states that the firm will replace any affected product once the form is received. Questions should be directed to 800-515-8112.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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