—#91338

Product

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

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K081643
Affected lot / code info: Lot# FD0110 Exp# 04/20/2010, Lot#FD0141, EXP# 05/21/2010, Lot# ED0155, EXP# 06/04/2010, Lot# EA0227, EXP# 08/15/2010, Lot# EB0247, EXP#09/04/2010, Lot# FA2096, EXP#10/23/2010, Lot#FC0310, EXP# 11/06/2010, Lot# FA0330, EXP# 11/26/2010.

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

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

Timeline

Recall initiated: 2010-04-12
Posted by FDA: 2010-11-24
Terminated: 2013-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91338. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.