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.
FDA Recall Z-1062-04 · Posted 2004-07-20
Advertisement
Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeDIP
Date Initiated2004-06-18
Date Terminated2004-10-06
Reason for Recall
May report falsely decreased patient results.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide, Canada, Germany and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement