—#33670

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.

FDA product code: DIP — Enzyme Immunoassay, Diphenylhydantoin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K030428
Affected lot / code info: Lot 14608300.

Why it was recalled

May report falsely decreased patient results.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide, Canada, Germany and Spain.

Timeline

Recall initiated: 2004-06-18
Posted by FDA: 2004-07-20
Terminated: 2004-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33670. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.