Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001.
FDA device recall Z-1113-05 · posted 2005-08-12 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Lack of adequate manufacturing controls.
- Action taken
- 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
- Status
- Terminated
- Product code
- LYW
- Quantity affected
- 1,005
- Distribution
- Nationwide.
- Date initiated
- 2005-05-03
- Date posted
- 2005-08-12
- Date terminated
- 2005-10-05
- Location
- Indianapolis, IN
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