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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device visual, pregnancy hcg, prescription use
Regulation Description Human chorionic gonadotropin (HCG) test system.
Product CodeJHI
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT
  SUBSTANTIALLY EQUIVALENT 15
BAYER
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BIOGENEX
  SUBSTANTIALLY EQUIVALENT 4
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 6
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 1
PHAMATECH
  SUBSTANTIALLY EQUIVALENT 3
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 20
UNIPATH
  SUBSTANTIALLY EQUIVALENT 5
WAMPOLE LABORATORIES,LLC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Incorrect or inadequate result 262
False negative result 101
Incorrect or inadequate test results 26
Low test results 11
Device displays error message 3
No Known Device Problem 3
High test results 3
Output, low 1
Device Issue 1
Cut in material 1
Total Device Problems 412

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 2 3 1 0 3 1 1 0 0 0
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostic International, Ltd. II Jul-12-2007
2 Alere San Diego, Inc. II May-25-2013
3 Alere San Diego, Inc. III May-21-2013
4 Applied Biotech Inc II Nov-21-2007
5 Beckman Coulter Inc. II Oct-17-2011
6 Beckman Coulter Inc. II Mar-21-2011
7 Innovacon Inc II May-06-2008
8 Mainline Technology, Inc. II Jan-15-2009
9 Quidel Corporation II Mar-01-2011
10 Siemens Healthcare Diagnostics II Feb-07-2012
11 Siemens Medical Solutions Diagnostics II Sep-01-2008
12 Siemens Medical Solutions Diagnostics II Sep-01-2008

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