Roche Diagnostics Corp. Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units.
Products Sold
All units.
Roche Diagnostics Corp. is recalling Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001. due to Lack of adequate manufacturing controls.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of adequate manufacturing controls.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026