Recall Z-2000-2009 ยท DKB Calibrators, Drug Mixture
Roche Diagnostics Corp.
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.
| Date | Sep 10, 2009 (initiated Apr 22, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 3,970 bottles of both products |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031856 | PRECISET TDM I AND PRECISET TDM II CALIBRATORS Roche Diagnostics Corp., Aug 6, 2003 |