FDA Device

Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.

Hazard

If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.

What You Should Do

Remedy

Roche sent each of their consignees revised Tecan database maintenance instruction via bulletin 04-042 dated 3/5/04.

Products

Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
Brand
Roche Diagnostics Corp.
UPC
Serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724.

Units Affected

14