Dimension Vista Iron Flex Reagent Cartridge and Calibrator

• • Terminated Z-0452-2013 FDA Class II ·initiated 8 Oct 2012

  Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources. All lots of IRON Flex(R) reagent cartridges have the potential for this issue. If a well set is contaminated with trace amounts of iron, the entire well set is impacted, and the mag

510(k) Number

K061793 ↗

FDA Product Code

JIY

Device Class

Class I

Regulation

21 CFR Part 862.1410

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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