Recall Z-0951-2009
Abbott Laboratories, Inc · initiated September 9, 2008
Product
ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
Codes / lots: Product Control/Lot #SK28.99
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 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.
Details
- Recall number
- Z-0951-2009
- Initiated
- September 9, 2008
- Posted by FDA
- February 5, 2009
- Terminated
- October 4, 2010
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 6
- Distribution
- Nationwide Distribution --- including states of TX, UT, and VA.
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX