Accu-Chek Advantage Blood Glucose System

• 2 recalls, same reason

  • Terminated Z-1354-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006
  • Terminated Z-1355-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006

  The meter gives a strip error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error and the manual only instructs the user to retest with a new strip using a larger drop of blood.

• 3 recalls, same reason

  • Terminated Z-1359-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006
  • Terminated Z-1358-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006
  • Terminated Z-1356-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006

  The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error.

• • Terminated Z-1357-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006

  The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that the test strip may be damaged or test was not performed correctly.

• 4 recalls, same reason

  • Terminated Z-1369-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006
  • Terminated Z-1362-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006
  • Terminated Z-1361-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006
  • Terminated Z-1360-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006

  The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.

510(k) Number

K930979 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Unimeter 330K

  Class II

  FDA 510(k) K822441 Active Cleared 8 Oct 1982

• Precinorm Hdl Cholesterol Control Material for Ref

  Class I

  FDA 510(k) K902569 Active Cleared 9 Aug 1990

• Precimat Glycerol

  Class I

  FDA 510(k) K780439 Active Cleared 18 Apr 1978

• Roche Diagnostics, Boehringer Mannheim Corporation Liquid Direct Bilirubin Reagent, Catalog Number 1877844

  Class II

  FDA 510(k) K981883 Active Cleared 7 Jul 1998

• Stattek Bun

  Class II

  FDA 510(k) K792328 Active Cleared 18 Dec 1979

• Softtouch II Lancet Device

  Class II

  FDA 510(k) K931258 Active Cleared 10 Feb 1994

See all devices from Boehringer Mannheim Corp. →