Accudata Glucose Test Station

• 3 recalls, same reason

  • Terminated Z-1368-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006
  • Terminated Z-1366-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006
  • Terminated Z-1367-06 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.

• 3 recalls, same reason

  • Terminated Z-0883-05 FDA Unclassified (pre-2012) ·initiated 18 Apr 2005
  • Terminated Z-0881-05 FDA Unclassified (pre-2012) ·initiated 18 Apr 2005
  • Terminated Z-0882-05 FDA Unclassified (pre-2012) ·initiated 18 Apr 2005

  If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.

510(k) Number

K924475 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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