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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 IIsee related information
Date Initiated by FirmApril 22, 2009
Date PostedSeptember 10, 2009
Recall Status1 Terminated 3 on December 07, 2009
Recall NumberZ-2001-2009
Recall Event ID 51896
510(K)NumberK031856 
Product Classification Calibrators, drug mixture - Product Code DKB
ProductRoche/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
ActionRoche 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 Commerce3,970 bottles of both products
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DKB
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