Recall Z-2154-2012 ยท GIM Tubes, Vacuum Sample, With Anticoagulant
Greiner Bio-One North America, Inc.
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.
| Date | Aug 7, 2012 (initiated Jul 2, 2012) |
| Status | Terminated |
| Reason | Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests. |
| Root cause | Nonconforming Material/Component |
| 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 an |
| Quantity | 838.9 cases (1,006,700 pieces) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971221 | GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc., May 2, 1997 |