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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assay, glycosylated hemoglobin
Regulation Description Glycosylated hemoglobin assay.
Product CodeLCP
Regulation Number 864.7470
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 8
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 5
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 15
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HOME ACCESS
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
  1.  K810638  LANCER GLYCOSYLATED HEMOGLOBIN
  2.  K810714  LANCER GLYCOSYLATED HEMOGLOBIN ASSAY
KULZER
  SUBSTANTIALLY EQUIVALENT 4
LXN CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
PACIFIC HEMOSTASIS
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 10
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 33
Device ingredient or reagent issue 29
Incorrect or inadequate test results 7
Low test results 5
Nonstandard device or device component 1
Device operates differently than expected 1
No Known Device Problem 1
Total Device Problems 77

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 2 2 4 4 1 2 4 2 1
Class III 0 0 0 1 5 0 0 1 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Alfa Wassermann, Inc. II Dec-17-2008
2 Bayer Healthcare Llc II Nov-02-2013
3 Beckman Coulter Inc. II May-10-2011
4 Bio-Rad Laboratories Inc III Jul-27-2011
5 Bio-Rad Laboratories Inc II Apr-11-2011
6 Bio-Rad Laboratories Inc II Apr-06-2011
7 Bio-Rad Laboratories Inc III Feb-17-2011
8 Bio-Rad Laboratories Inc II Feb-15-2011
9 Bio-Rad Laboratories Inc II Oct-22-2010
10 Bio-Rad Laboratories Inc II Oct-21-2010
11 Bio-Rad Laboratories Inc II Jun-25-2010
12 Bio-Rad Laboratories Inc III Mar-05-2010
13 Bio-Rad Laboratories Inc II Feb-26-2010
14 Bio-Rad Laboratories Inc II May-19-2009
15 Bio-Rad Laboratories Inc II Mar-24-2009
16 Bio-Rad Laboratories, Inc. II Jan-27-2016
17 Bio-Rad Laboratories, Inc. II Mar-27-2014
18 Bio-Rad Laboratories, Inc. III Feb-10-2014
19 Bio-Rad Laboratories, Inc. III Oct-07-2011
20 Bio-Rad Laboratories, Inc. III Sep-06-2011
21 Bio-Rad Laboratories, Inc., Hercules, CA III Apr-13-2011
22 Cholestech Corp II Sep-23-2008
23 Heritage Labs International LLC II Jan-11-2012
24 Metrika Inc II Jun-25-2015
25 Siemens Healthcare Diagnostics II Sep-03-2013
26 Siemens Healthcare Diagnostics, Inc. II Nov-25-2015
27 Siemens Healthcare Diagnostics, Inc. II Nov-21-2014
28 Siemens Healthcare Diagnostics, Inc. II Oct-24-2014
29 Siemens Healthcare Diagnostics, Inc. II Jan-03-2014
30 Tosoh Bioscience, Inc. III Jul-14-2015

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