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.
This recall has been terminated (originally issued September 10, 2009).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- April 22, 2009
- Posted
- September 10, 2009
- Terminated
- December 7, 2009
- Recall Number
- Z-2000-2009
- Quantity
- 3,970 bottles of both products
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution
Lot / Code Info
Lot Numbers: 15617400 and 15612200.
Root Cause
Packaging process control
Action Taken
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.
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