FDA Device

Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001.

Hazard

Lack of adequate manufacturing controls.

What You Should Do

Remedy

Consignees were notified via letter dated 5/3/05. Customers were requested to discard their device and to respond to Roche for a refund. The firm''s internet support site for the system is being turned off.

Products

Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001.
Brand
Roche Diagnostics Corp.
UPC
All units.

Units Affected

1,005