Accu-Chek Advantage Test Strips and Accu-Chek Advantage H Test Strips

• • Terminated Z-1378-06 FDA Unclassified (pre-2012) ·initiated 27 Jun 2006

  The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results

• 4 recalls, same reason

  • Terminated Z-0569-06 FDA Unclassified (pre-2012) ·initiated 10 Feb 2006
  • Terminated Z-0567-06 FDA Unclassified (pre-2012) ·initiated 10 Feb 2006
  • Terminated Z-0570-06 FDA Unclassified (pre-2012) ·initiated 10 Feb 2006
  • Terminated Z-0568-06 FDA Unclassified (pre-2012) ·initiated 10 Feb 2006

  There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.

• • Terminated Z-0573-06 FDA Unclassified (pre-2012) ·initiated 10 Feb 2006

  There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings..

• • Terminated Z-0716-03 FDA Unclassified (pre-2012) ·initiated 12 Feb 2003

  Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.

510(k) Number

K982089 ↗

FDA Product Code

LFR

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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