Recall Z-0461-2011
Siemens Healthcare Diagnostics, Inc. · initiated April 12, 2010
Product
The Dimension NTP and LNTP Flex reagent cartridge (N- Terminal Pro- Brain Natriuretic Peptide and N-Terminal Pro brain Natriuretic Peptide (low volume)
Codes / lots: Lot# FD0110 Exp# 04/20/2010, Lot#EB0122, EXP# 05/02/2010, Lot# FC0190, EXP# 07/09/2010, Lot# FC0219, EXP# 08/07/2010, Lot# FB0256, EXP#09/13/2010, Lot# FC0100, EXP#04/10/2010, Lot#EA0122, EXP#02/05/2010, Lot# FB0190, EXP# 07/09/2010, Lot# FB0219, EXP# 08/07/2010, lot# FA0256, EXP# 09/13/2010.
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.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-0461-2011
- Initiated
- April 12, 2010
- Posted by FDA
- November 24, 2010
- Terminated
- March 19, 2013
- Product code
- NBC – Test, Natriuretic Peptide
- Quantity
- 3364
- Distribution
- Worldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0458-2011 | The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens…Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high… | 04/12/2010Terminated |
| Z-0459-2011 | The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by…Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high… | 04/12/2010Terminated |
| Z-0460-2011 | The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens…Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high… | 04/12/2010Terminated |