Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, and Glucose Control Solutions (Low and High)

• • Ongoing Z-2881-2016 FDA Class II ·initiated 28 Jun 2016

  Product gives incorrect low blood glucose levels.

• • Terminated Z-0910-2014 FDA Class II ·initiated 2 Oct 2013

  Manufactured with an incorrect factory set unit of measure.

• • Terminated Z-1140-2013 FDA Class II ·initiated 25 Feb 2013

  Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.

510(k) Number

K032657 ↗

FDA Product Code

NBW

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• TRUE2GO Blood Glucose System, Model F4H01-81 Open recall

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• Prestige Lx Blood Glucose Test System

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• Modification to Truetrack Smart System Blood Glucose Meter, Test Strips and Glucose Control

  Class II

  FDA 510(k) K040670 Active Cleared 25 Mar 2004

• Truebalance Blood Glucose System Open recall

  Class II

  FDA 510(k) K090495 Active Cleared 27 Mar 2009

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