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Terminated

ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco SpA, Segrate (MI), Italy.

FDA Recall Z-0951-2009 · Posted 2009-02-05

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJQP
Date Initiated2008-09-09
Date Terminated2010-10-04
Product Quantity6

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution --- including states of TX, UT, and VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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