Recall Z-2000-2009
Roche Diagnostics Corp. · initiated April 22, 2009
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.
Codes / lots: Lot Numbers: 15617400 and 15612200.
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: 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.
Details
- Recall number
- Z-2000-2009
- Initiated
- April 22, 2009
- Posted by FDA
- September 10, 2009
- Terminated
- December 7, 2009
- Product code
- DKB – Calibrators, Drug Mixture
- Quantity
- 3,970 bottles of both products
- Distribution
- Nationwide Distribution
- Recalling firm
- Roche Diagnostics Corp., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2001-2009 | Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781…The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the… | 04/22/2009Terminated |