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.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- June 18, 2004
- Posted
- July 20, 2004
- Terminated
- October 6, 2004
- Recall Number
- Z-1062-04
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
May report falsely decreased patient results.
Distribution
Nationwide, Canada, Germany and Spain.
Lot / Code Info
Lot 14608300.
Root Cause
Other
Action Taken
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.
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