FDA Device

Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.

Hazard

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

What You Should Do

Remedy

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

Products

Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.
Brand
Roche Diagnostics Corp.
UPC
All units (serial numbers 5583, 5606, 6372, 6394, 6396, 6398, 6558, 7210, 7574, 7595 and 7615).

Units Affected

11