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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device multi-analyte controls, all kinds (assayed)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJY
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 10
BAYER
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 6
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 10
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 78
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 17
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CHOLESTECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 8
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 6
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 4
I-STAT
  SUBSTANTIALLY EQUIVALENT 1
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 8
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 5
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 25
SCANTIBODIES
  SUBSTANTIALLY EQUIVALENT 3
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Incorrect or inadequate test results 4
Human-Device Interface Issue 2
Difficult to open or close 1
No code available 1
Incorrect or inadequate result 1
Device handling issue 1
Total Device Problems 10

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point of Care Inc. II Feb-02-2011
2 Alere San Diego, Inc. III Oct-15-2015
3 Alere San Diego, Inc. III Jan-29-2013
4 Bio-rad Laboratories, Inc. III May-16-2013
5 Biosite Inc II Jun-11-2010
6 Biosite Inc Dba Innovacon Inc. II Nov-22-2010
7 Horiba Instruments, Inc dba Horiba Medical III Feb-03-2014
8 Horiba Instruments, Inc dba Horiba Medical II Jan-31-2014
9 MedtestDx, Inc. II Sep-15-2015
10 Microgenics Corporation II Dec-04-2014
11 Microgenics Corporation III Jun-26-2014
12 Microgenics Corporation III Nov-19-2012
13 Microgenics Corporation II Jan-11-2012
14 Quantimetrix Corporation II Jan-17-2009
15 Roche Diagnostics Corp. II Mar-04-2008
16 Roche Diagnostics Corp. II Dec-29-2007
17 Siemens Healthcare Diagnostics, Inc. III Nov-13-2014
18 Vital Diagnostics, Inc. II Apr-06-2010

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