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U.S. Department of Health and Human Services

Class 2 Device Recall ACCELERATOR APS Cetrifuge Module

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  Class 2 Device Recall ACCELERATOR APS Cetrifuge Module see related information
Date Initiated by Firm September 09, 2008
Date Posted February 05, 2009
Recall Status1 Terminated 3 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 2
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.
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