Roche/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.
FDA Recall Z-2001-2009 · Posted 2009-09-10
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Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeDKB
Date Initiated2009-04-22
Date Terminated2009-12-07
Product Quantity3,970 bottles of both products
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.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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