Z-1063-04

Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml...

Name: Z-1063-04 Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml...
Creator: Roche Diagnostics Corp.
Published: 2004-06-18
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2004-06-18 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml anti-phenytoin antibody (mouse monoclonal); latex... on 2004-06-18. The reason FDA records is "May report falsely decreased patient results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1063-04
Status: Terminated
Initiated: 2004-06-18
Posted: 2004-07-20
Terminated: 2004-10-06
Recalling firm: Roche Diagnostics GmbH
Product: Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03516989190.
Product code: DIP Enzyme Immunoassay, Diphenylhydantoin
Reason for recall: May report falsely decreased patient results.
FDA root cause: Other
Action: Consignees were maile a recall letter dated 6/17/04 on 6/18/04 instructing them to cease using this lot and to advise all attending physicians of the problem.
Distribution: Nationwide, Canada, Germany and Spain.
Product codes and lots: Lot 14608300.

Product code DIP

K030428Class IIRoche Online Tdm PhenytoinRoche Diagnostics Corp. / cleared 2003-04-28

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)