Z-2001-2009

Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator...

Name: Z-2001-2009 Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator...
Creator: Roche Diagnostics Corp.
Published: 2009-04-22
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2009-04-22 / Terminated / root cause: packaging

FDA source

Roche Diagnostics Corp. began a recall of Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator designed for the calibration of Roche assays for the... on 2009-04-22. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2001-2009
Status: Terminated
Initiated: 2009-04-22
Posted: 2009-09-10
Terminated: 2009-12-07
Recalling firm: Roche Diagnostics GmbH
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.
Product code: DKB Calibrators, Drug Mixture
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.
Root cause tag: packaging
FDA 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 in commerce: 3,970 bottles of both products
Distribution: Nationwide Distribution
Product codes and lots: Lot Number: 15612300.

Product code DKB

K031856Class IIPreciset Tdm I and Preciset Tdm II CalibratorsRoche Diagnostics Corp. / cleared 2003-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)