Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenyt
FDA device recall Z-1062-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- May report falsely decreased patient results.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DIP
- Distribution
- Nationwide, Canada, Germany and Spain.
- Date initiated
- 2004-06-18
- Date posted
- 2004-07-20
- Date terminated
- 2004-10-06
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROCHE ONLINE TDM PHENYTOIN (K030428) | Roche Diagnostics Corp. | 2003-04-28 |