Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Affymetrix, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35175
  • Event Risk Class
    Class 3
  • Event Number
    Z-0853-06
  • Event Initiated Date
    2005-04-26
  • Event Date Posted
    2006-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45455
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    GeneChip Microarray Instrumentation System - Product Code NSU
  • Reason
    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.
  • 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.

Device

Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with...
  • Model / Serial
    Serial Numbers:  7SLJX61 - GX280 ;  3V35V61-GX280;  6SLJX61 - GX280; 7S35V61 - GX280;  FT35V61 -GX280; GS35V61 - GX280; JT35V61 -GX280; 1V35V61 - GX280; 4V35V61 -GX280; 8V35V61 - GX280; DT35V61 - GX280; BV35V61 -GX280; JV35V61 -GX280; GV35V61 - GX280; JS35V61 -GX280; BPB1761 - GX280;
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California and Indiana Foreign: The Netherlands, Switzerland
  • Product Description
    Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software
  • Manufacturer
    Affymetrix, Inc.

Manufacturer

Affymetrix, Inc.
  • Manufacturer Address
    Affymetrix, Inc., 4G Crosby Dr, Bedford MA 01730-1402
  • Source
    USFDA