Date Initiated by Firm |
April 22, 2009 |
Date Posted |
September 10, 2009 |
Recall Status1 |
Terminated 3 on December 07, 2009 |
Recall Number |
Z-2000-2009 |
Recall Event ID |
51896 |
510(K)Number |
K031856
|
Product Classification |
Calibrators, drug mixture - Product Code DKB
|
Product |
Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190.
Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma. |
Code Information |
Lot Numbers: 15617400 and 15612200. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact |
800-428-2336
|
Manufacturer Reason for Recall |
The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Roche Diagnostics Corp. notified Consignees via letter dated April 22, 2009 and instructed to not use excessive force when opening bottles and contact the firm for product replacement instead. A Fax Back Form was included for customers to return via fax to 1-888-345-0480.
For further information, contact your Roche Diagnostics representative or call 1-800-428-5074. |
Quantity in Commerce |
3,970 bottles of both products |
Distribution |
Nationwide Distribution |
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 = DKB and Original Applicant = ROCHE DIAGNOSTICS CORP.
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