Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0951-2009

ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by...

Abbott Medical / initiated 2008-09-09 / Terminated / root cause: design

Abbott Laboratories, Inc began a recall of ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco SpA, Segrate (MI), Italy on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0951-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Abbott Medical
Product
ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag
design
FDA root 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.
Product codes and lots
Product Control/Lot #SK28.99