FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
- Recall number
- Z-0459-2011
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
- Status
- Terminated
- Initiated
- 2010-04-12
- Posted
- 2010-11-24
- Terminated
- 2013-03-19
- Reason
- 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
- 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
- 4187
- Distribution
- Worldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K081074"]
- PMA numbers
- not on file
- Product code
- JLW
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28