Class 2 Device Recall ACCELERATOR APS Cetrifuge Module

• Date Initiated by Firm: September 09, 2008
• Date Posted: February 05, 2009
• Recall Status: Terminated on October 04, 2010
• Recall Number: Z-0951-2009
• Recall Event ID: 49474
• Product Classification: Calculator/Data Processing Module for Clinical Use - Product Code JQP
• Product: ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
• Code Information: Product Control/Lot #SK28.99
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Drive; PO Box 152020; Irving TX 75038-4313
• For Additional Information Contact: 972-518-6000
• Manufacturer Reason for Recall: ACCELERATOR APS Centrifuge Module being recalled due to potential for micro-cracks to form over time in the metal centrifuge rotor buckets that may cause the centrifuge buckets to disconnect from the rotor in the centrifuge during centrifugation.
• FDA Determined Cause: Device Design
• Action: Notification letters sent to consignees on 09/09/08. Consignees provided instructions for inspecting the buckets for cracks and were asked to contact customer service reps for replacement buckets. Consignees also asked to respond via fax using Customer Reply form acknowledging receipt, understanding and completion of correction letter.
• Quantity in Commerce: 6
• Distribution: Nationwide Distribution --- including states of TX, UT, and VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.