Recall Z-0951-2009 ยท JQP Calculator/Data Processing Module, For Clinical Use
Abbott Laboratories, Inc
ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
| Date | Feb 5, 2009 (initiated Sep 9, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 6 |
| Distribution | Nationwide Distribution --- including states of TX, UT, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.