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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device single (specified) analyte controls (assayed and unassayed)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJX
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
AMIRA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 10
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 22
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 22
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 24
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 3
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 9
DIASORIN
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
HOME DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 1
IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
I-STAT
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
KULZER
  SUBSTANTIALLY EQUIVALENT 1
LXN CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 14
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 2
Quantimetrix Corporation
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 5
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 60
SIEMENS
  SUBSTANTIALLY EQUIVALENT 16
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNIPATH
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Incorrect or inadequate result 7
Device operates differently than expected 4
Improper or incorrect procedure or method 2
High test results 2
Data Issue 1
Other (for use when an appropriate device code cannot be identified) 1
Incorrect or inadequate test results 1
Incorrect display 1
Device expiration issue 1
Use of Incorrect Control Settings 1
Total Device Problems 21

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Oct-24-2014
2 Abbott Laboratories II May-29-2014
3 Abbott Laboratories III Nov-13-2008
4 Abbott Laboratories III Jul-31-2008
5 Abbott Laboratories II Sep-18-2007
6 Abbott Point Of Care Inc. II Apr-01-2011
7 AmniSure International LLC II Jan-19-2008
8 Bayer Healthcare, LLC II Aug-29-2015
9 Beckman Coulter Inc. II Mar-21-2012
10 Beckman Coulter Inc. II Jun-21-2011
11 Beckman Coulter Inc. III Aug-11-2010
12 Bio-Rad Laboratories, Inc. III Jun-25-2015
13 Biochemical Diagnostics Inc III Nov-23-2015
14 Lifescan Inc II Apr-17-2013
15 Microgenics Corporation II Jun-21-2013
16 Tosoh Bioscience Inc III Oct-03-2007

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