Recall Z-1063-04 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
Roche Diagnostics Corp.
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.
| Date | Jul 20, 2004 (initiated Jun 18, 2004) |
| Status | Terminated |
| Reason | May report falsely decreased patient results. |
| Root cause | Other |
| 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. |
| Distribution | Nationwide, Canada, Germany and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030428 | ROCHE ONLINE TDM PHENYTOIN Roche Diagnostics Corp., Apr 28, 2003 |