RecallDepth

Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.

Company
Greiner Bio-One North America, Inc.
Recall Initiated
August 12, 2011
Posted
November 14, 2011
Terminated
March 12, 2012
Recall Number
Z-0184-2012
Quantity
504,000 pieces
Firm Location
Monroe, NC

Reason for Recall

Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.

Distribution

Nationwide.

Lot / Code Info

Item #454209, Lot #B051111.

Root Cause

Process control

Action Taken

Consignees were notified by Greiner bio-one letter on August 11, 2011. They were instructed to: Stop distributing the material, complete the product Disposition form attach and to fax it to Greiner bio-one and to destroy or return any of the affected products for replacement or credit. Distributors were asked to provide a list of their customers that have received the item, preferably in an Excel file, so that they could be notified of the recall.

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