Recall Z-0459-2011 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Siemens Healthcare Diagnostics, Inc.
The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
| Date | Nov 24, 2010 (initiated Apr 12, 2010) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081074 | DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 Siemens Healthcare Diagnostics, Inc., May 23, 2008 |