Devices

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.

Model / Serial
Lot 14608300.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Canada, Germany and Spain.
Product Description
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.
Manufacturer
Roche Diagnostics Corp.
1 Event
- 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 microparticle. Product 03516989190.

Manufacturer

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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