Dimension Iron Flex Reagent Cartridge (Iron-DF85)

• 2 recalls, same reason

  • Terminated Z-0402-2017 FDA Class III ·initiated 25 Aug 2016
  • Terminated Z-0401-2017 FDA Class III ·initiated 25 Aug 2016

  Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).

510(k) Number

K060264 ↗

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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  Class II

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• Tgl Flex Reagent Cartridge

  Class I

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