Recalls / —

—#33084

Product

Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.

FDA product code

JQW — Station, Pipetting And Diluting, For Clinical Use

Device class

Class 1

Medical specialty

Clinical Chemistry

Affected lot / code info

All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768).

Why it was recalled

Tecan software has the potential to match the patient with a different patient's test results.

Root cause (FDA determination)

Other

Action the firm took

Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to user laboratories.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

Nationwide. California, Connecticut, Georgia, Illinois, Maryland, Massachusetts, Michigan, New Jersey, Pennsylvania, Tennessee, Texas and Wisconsin.

Timeline

Recall initiated

2004-05-05

Posted by FDA

2004-07-20

Terminated

2007-07-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #33084. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.