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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmApril 26, 2005
Date PostedMay 06, 2006
Recall Status1 Terminated 3 on December 13, 2006
Recall NumberZ-0853-06
Recall Event ID 35175
Product Classification GeneChip Microarray Instrumentation System - Product Code NSU
ProductAffymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software
Code Information 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;  
FEI Number 3003314809
Recalling Firm/
Manufacturer		 Affymetrix, Inc.
4G Crosby Dr
Bedford MA 01730-1402
For Additional Information ContactElizabeth Mansfield PhD
408-731-5278
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionAfffymetrix 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.
Quantity in Commerce13 units
DistributionCalifornia and Indiana Foreign: The Netherlands, Switzerland
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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