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Terminated

Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software

FDA Recall Z-0853-06 · Posted 2006-05-06

Recalling FirmAffymetrix, Inc.
Recall StatusTerminated
Product CodeNSU
Date Initiated2005-04-26
Date Terminated2006-12-13
Product Quantity13 units

Reason for Recall

Incorrect software version of instrument controller is not compatible with new configuration. This incorrect configuration may cause the instrument system to fail at start-up or during a run.

Firm Action

Afffymetrix notified the two hospitals by email dated 4/14/05 and by letter to the Distributor on 4/28/05. Affymetrix service personnel will be provided with discs to perform the software update. All field changes will be documented via Service Work Orders.

Root Cause

Other

Distribution Pattern

California and Indiana Foreign: The Netherlands, Switzerland

Official Source

View FDA Recall →

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

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