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Terminated

The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.

FDA Recall Z-0460-2011 · Posted 2010-11-24

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeMMI
Date Initiated2010-04-12
Date Terminated2013-03-19
Product Quantity4966

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081643DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692Siemens Healthcare Diagnostics · 2008-07-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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