D-10 Hemoglobin A1C

• • Terminated Z-1299-2014 FDA Class II ·initiated 27 Feb 2014

  On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.

• • Terminated Z-0965-2014 FDA Class III ·initiated 22 Nov 2013

  D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.

• 3 recalls, same reason

  • Terminated Z-0017-2012 FDA Unclassified (pre-2012) ·initiated 12 Sep 2011
  • Terminated Z-0019-2012 FDA Unclassified (pre-2012) ·initiated 12 Sep 2011
  • Terminated Z-0018-2012 FDA Unclassified (pre-2012) ·initiated 12 Sep 2011

  A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.

• • Terminated Z-1969-2011 FDA Unclassified (pre-2012) ·initiated 8 Sep 2010

  The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for the Calibrator/Diluent Set is: S01704.

510(k) Number

K031043 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class II

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  Class II

  FDA 510(k) K130053 Active Cleared 19 Sep 2013

• Access Ck-Mb Reagents

  Class II

  FDA 510(k) K945083 Active Cleared 21 Nov 1994

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