Z-1113-05

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

Name: Z-1113-05 Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001
Creator: Roche Diagnostics Corp.
Published: 2005-05-03
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2005-05-03 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corp. began a recall of Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001 on 2005-05-03. The reason FDA records is "Lack of adequate manufacturing controls". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1113-05
Status: Terminated
Initiated: 2005-05-03
Posted: 2005-08-12
Terminated: 2005-10-05
Recalling firm: Roche Diagnostics GmbH
Product: Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001.
Product code: LYW
Reason for recall: Lack of adequate manufacturing controls.
Root cause tag: manufacturing process
FDA root cause: Other
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.
Quantity in commerce: 1,005
Distribution: Nationwide.
Product codes and lots: All units.

Product code LYW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)