The Dimension NTP and LNTP Flex reagent cartridge (N-… recallZ-0461-2011 · Siemens Healthcare Diagnostics, Inc. · initiated Apr 12, 2010
Terminated All recalls posted in November 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0461-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 12, 2010
- Posted by the FDA
- Nov 24, 2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 3364
- Product code
- NBC
- FDA submissions
- K082645
- Distribution
- Worldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia.
Product description
The Dimension NTP and LNTP Flex reagent cartridge (N- Terminal Pro- Brain Natriuretic Peptide and N-Terminal Pro brain Natriuretic Peptide (low volume)
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
1 device cleared under K082645 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension® EXL™ LOCI® Module Flex® reagent cartridge NTP 10464526Siemens Healthcare Diagnostics Inc. · TEST,NATRIURETIC PEPTIDE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 55604).
- Z-0460-2011 · TerminatedThe Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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