Recalls / —

—#38597

Product

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

FDA product code

LYW

Affected lot / code info

All units.

Why it was recalled

Lack of adequate manufacturing controls.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2005-05-03

Posted by FDA

2005-08-12

Terminated

2005-10-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #38597. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.