Recall Z-0460-2011 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc.
The Dimension TNI Flex reagent cartridge (Cardiac Troponin), 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 | 4966 |
| 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
| K081643 | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 Siemens Healthcare Diagnostics, Jul 3, 2008 |