ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
This recall has been terminated (originally issued February 5, 2009).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- September 9, 2008
- Posted
- February 5, 2009
- Terminated
- October 4, 2010
- Recall Number
- Z-0951-2009
- Quantity
- 6
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution --- including states of TX, UT, and VA.
Lot / Code Info
Product Control/Lot #SK28.99
Root Cause
Device Design
Action Taken
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.