Date Initiated by Firm |
June 18, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on October 06, 2004 |
Recall Number |
Z-1063-04 |
Recall Event ID |
29329 |
510(K)Number |
K030428
|
Product Classification |
Enzyme Immunoassay, Diphenylhydantoin - Product Code DIP
|
Product |
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 |
Lot 14608300. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact |
Technical Support 800-428-2336
|
Manufacturer Reason for Recall |
May report falsely decreased patient results.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DIP and Original Applicant = ROCHE DIAGNOSTICS CORP.
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