ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco SpA, Segr
FDA device recall Z-0951-2009 · posted 2009-02-05 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 6
- Distribution
- Nationwide Distribution --- including states of TX, UT, and VA.
- Date initiated
- 2008-09-09
- Date posted
- 2009-02-05
- Date terminated
- 2010-10-04
- Location
- Irving, TX
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