Recall Z-0853-06 ยท NSU Instrumentation For Clinical Multiplex Test Systems
Affymetrix, Inc.
Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software
| Date | May 6, 2006 (initiated Apr 26, 2005) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.