Roche/Hitachi brand ONLINE TDM Phenytoin recallZ-1063-04 · Roche Diagnostics Corp. · initiated Jun 18, 2004
Terminated All recalls posted in July 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
May report falsely decreased patient results.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1063-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 18, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Roche Diagnostics Corp.
- Product code
- DIP
- FDA submissions
- K030428
- 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.
Code information (models, lots, serial numbers)
Lot 14608300.
Other devices under the same FDA submission
1 device cleared under K030428 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ONLINE TDM Phenytoin 08445567190Roche Diagnostics GmbH · ENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 29329).
- Z-1062-04 · TerminatedRoche/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. Pro…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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