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Terminated

Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064

FDA Recall Z-0257-2008 · Posted 2007-11-24

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJQP
Date Initiated2007-10-10
Date Terminated2008-03-10
Product Quantity1 unit.

Reason for Recall

Sample problems; Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube carrier is not performed and the APS work cell may not appropriately generate Sample Presentation/Sample Queue errors with APS software version 1.1.1 or earlie

Firm Action

Firm notified consignee via letter on 11/10/07. Consignee notified of software issues and informed they would be contacted by an Abbott representative to schedule installation of software upgrade.

Root Cause

Software design

Distribution Pattern

Nationwide: including state of UT.

Official Source

View FDA Recall →

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

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