Z-0459-2011

The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare...

Name: Z-0459-2011 The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-04-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-04-12 / Terminated / root cause: packaging

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE on 2010-04-12. The reason FDA records is "Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results". 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-0459-2011
Status: Terminated
Initiated: 2010-04-12
Posted: 2010-11-24
Terminated: 2013-03-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results.
Root cause tag: packaging
FDA root cause: Other
Action: Siemens issued an "Urgent Field Safety Notice" dated April 2010, informing users of the problem and instructing them to inspect cartridges for leaking fluid. Cartridges with leaking fluid should be reported to the Siemens Technical Solutions Center. The Technical Solutions Center can be contacted at 800 441 9250.
Quantity in commerce: 4187
Distribution: Worldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia.
Product codes and lots: Lot# FJ0103 Exp# 04/12/2010, Lot# EE0166, EXP# 06/15/2010, Lot# EA0185, EXP# 07/04/2010, Lot# FA0199, EXP# 07/18/2010, Lot# EC0266, EXP#08/14/2010, Lot# FC0262, EXP#09/19/2010, Lot#FB1068, EXP# 03/09/2011.

Product code JLW

K081074Class IIDimension Tshl Flex Reagent Cartridge and Tsh Sample Diluent with Models RF 612 and Kd691Siemens Healthcare Diagnostics, Inc. / cleared 2008-05-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)