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U.S. Department of Health and Human Services

Class 2 Device Recall Roche/Hitachi Preciset TDM II

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  Class 2 Device Recall Roche/Hitachi Preciset TDM II see related information
Date Initiated by Firm April 22, 2009
Date Posted September 10, 2009
Recall Status1 Terminated 3 on December 07, 2009
Recall Number Z-2001-2009
Recall Event ID 51896
510(K)Number K031856  
Product Classification Calibrators, drug mixture - Product Code DKB
Product Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 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 Number: 15612300.
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

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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