Device Recall 3mL 9NC Coagulation Sodium Citrate 3.2 의 리콜

Recall

62595

Class 2

Z-2154-2012

2012-07-02

2012-08-07

Terminated

United States

2013-06-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111118

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

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.