—#81605

Product

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 product code: DKB — Calibrators, Drug Mixture
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K031856
Affected lot / code info: Lot Number: 15612300.

Why it was recalled

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 (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2009-04-22
Posted by FDA: 2009-09-10
Terminated: 2009-12-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81605. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.