Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716,

• • Terminated Z-0399-2012 FDA Unclassified (pre-2012) ·initiated 25 Oct 2011 ·on shared 510(k) K070819

  It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.

• 2 recalls, same reason

  • Terminated Z-0027-2012 FDA Unclassified (pre-2012) ·initiated 12 Sep 2011
  • Terminated Z-0026-2012 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-3159-2011 FDA Unclassified (pre-2012) ·initiated 28 Jul 2011

  The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle.

• • Terminated Z-1259-2011 FDA Unclassified (pre-2012) ·initiated 19 Feb 2010

  The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K070819 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Variant Nbs Sickle Cell Program Reagent Kit, Variant Nbs Newborn Screening System and Variant Nbs Workstation with

  Class II

  FDA 510(k) K080911 Active Cleared 2 May 2008

• Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing System

  Class II

  FDA 510(k) K122472 Active Cleared 26 Oct 2012

• Variant(Tm) II Turbo HBA1C Kit - 2.0

  Class II

  FDA 510(k) K130990 Active Cleared 9 May 2013

• Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total Ghb Program

  Class II

  FDA 510(k) K063643 Active Cleared 27 Dec 2006

• Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with Cdm Software, Cdm Software

  Class II

  FDA 510(k) K130860 Active Cleared 25 Apr 2013