Recalls / —

—#33083

Product

Tecan clinical workstation; 10-415 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

Affected lot / code info

All units (serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724).

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 #33083. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.