FDA Medical Device Recalls (openFDA)
Affymetrix, Inc.: Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software
- Recall number
- Z-0853-06
- Recalling firm
- Affymetrix, Inc.
- Product
- Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software
- Status
- Terminated
- Initiated
- 2005-04-26
- Posted
- 2006-05-06
- Terminated
- 2006-12-13
- 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.
- 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
- 13 units
- Distribution
- California and Indiana Foreign: The Netherlands, Switzerland
- Lot, serial or model codes
- 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;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NSU
- Firm FEI
- 3003314809
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28