The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare Diagnostics,
FDA device recall Z-0459-2011 · posted 2010-11-24 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JLW
- Quantity affected
- 4187
- Distribution
- Worldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia.
- Date initiated
- 2010-04-12
- Date posted
- 2010-11-24
- Date terminated
- 2013-03-19
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 (K081074) | Siemens Healthcare Diagnostics, Inc. | 2008-05-23 |