Recall Z-0461-2011 ยท NBC Test, Natriuretic Peptide
Siemens Healthcare Diagnostics, Inc.
The Dimension NTP and LNTP Flex reagent cartridge (N- Terminal Pro- Brain Natriuretic Peptide and N-Terminal Pro brain Natriuretic Peptide (low volume)
| 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 | 3364 |
| 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
| K082645 | DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 Siemens Healthcare Diagnostics, Sep 22, 2008 |