Z-0853-06

Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader...

Name: Z-0853-06 Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader...
Creator: Affymetrix, Inc.
Published: 2005-04-26
License: https://open.fda.gov/license/

Affymetrix Inc / initiated 2005-04-26 / Terminated / root cause: software

FDA source

Affymetrix, Inc. began a recall of Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software on 2005-04-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0853-06
Status: Terminated
Initiated: 2005-04-26
Posted: 2006-05-06
Terminated: 2006-12-13
Recalling firm: Affymetrix Inc
Product: Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software
Product code: NSU Instrumentation For Clinical Multiplex Test Systems
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.
Root cause tag: software
FDA root cause: Other
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.
Quantity in commerce: 13 units
Distribution: California and Indiana Foreign: The Netherlands, Switzerland
Product codes and lots: 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 code NSU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)