FDA Device

Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03800458190.

Hazard

May report falsely decreased patient results.

What You Should Do

Remedy

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.

Products

Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03800458190.
Brand
Roche Diagnostics Corp.
UPC
Lot 14608300.