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Terminated

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

FDA Recall Z-1113-05 · Posted 2005-08-12

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLYW
Date Initiated2005-05-03
Date Terminated2005-10-05
Product Quantity1,005

Reason for Recall

Lack of adequate manufacturing controls.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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