—#32915

Product

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

FDA product code: JQW — Station, Pipetting And Diluting, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K953345
Affected lot / code info: Serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.

Timeline

Recall initiated: 2004-03-05
Posted by FDA: 2004-07-20
Terminated: 2007-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32915. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.