Company:Affymetrix, Inc.,
Date of Enforcement Report:5/17/2006
Class:lIl
PRODUCT
Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software, Recall # Z-0853-06
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.
CODE
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
RECALLING FIRM/MANUFACTURER
Affymetrix, Inc, Bedford, MA, by email dated April 14, 2005 and by letter on December 28, 2005. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
CA, IN, The Netherlands, and Switzerland
