Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control Low, Medium, High

• • Terminated Z-2241-2016 FDA Class II ·initiated 17 May 2016

  Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.

• • Terminated Z-0541-2014 FDA Class II ·initiated 18 Sep 2013

  Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.

• • Terminated Z-0253-2013 FDA Class III ·initiated 3 Aug 2012

  Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.

510(k) Number

K063206 ↗

FDA Product Code

LPS

Models / Variants

Dimension Vista Hcys Flex Reagent Cartridge

Protein 1 Calibrator

Protein 1 Control Low, Medium, High

Device Class

Class II

Regulation

21 CFR Part 862.1377

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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