Affymetrix, Inc. Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software
Brand
Affymetrix, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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;
Affymetrix, Inc. is recalling Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with au due to Incorrect software version of instrument controller is not compatible with new configuration. This incorrect configuration may cause the instrument sy. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN
Page updated: Jan 10, 2026