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.
Hazard
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.
What You Should Do
Remedy
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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Products
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 dr
- Brand
- Roche Diagnostics Corp.
- UPC
- Lot Numbers: 15617400 and 15612200.
Units Affected
3,970 bottles of both products