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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device calibrator, multi-analyte mixture
Regulation Description Calibrator.
Product CodeJIX
Regulation Number 862.1150
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
BAYER
  SUBSTANTIALLY EQUIVALENT 6
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 3
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 8
  1.  K810964  BIO SET TM PHOSPHOROUS CALIBRATOR
  2.  K811921  HITACHI 705 CALIBRATOR
  3.  K961659  CEDIA CORE TDM MULTI-CAL
  4.  K962269  CEDIA CARDIAC TDM MULTI-CALS
  5.  K964829  ELECSYS CALCHECK FSH
  6.  K974825  BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS
  7.  K983469  PRECISET SERUM PROTEINS CALIBRATOR
  8.  K984425  MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 18
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 3
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 1
FISHER
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 4
NOVA
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 4
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 4
RAICHEM
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 23
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Low test results 152
High test results 94
High Readings 77
Calibration error 50
Malfunction 31
Miscalibration 31
Incorrect or inadequate test results 7
Failure to recalibrate 2
Failure to calibrate 1
Low readings 1
Total Device Problems 446

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 0 3 2 0 2 0 7 2 1
Class III 2 0 1 1 0 1 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. II Jun-25-2015
2 Abbott Laboratories Inc. II Feb-06-2009
3 Abbott Laboratories Inc. II Jan-12-2009
4 Beckman Coulter Inc. III Oct-22-2012
5 Cargille-Sacher Laboratories Inc. III Dec-01-2009
6 Diagnostic Chemicals, Ltd. III Feb-27-2007
7 Horiba Instruments, Inc dba Horiba Medical II Mar-05-2014
8 Mega Diagnostics III Apr-14-2007
9 Ortho-Clinical Diagnostics II Aug-13-2014
10 Ortho-Clinical Diagnostics II Feb-25-2014
11 Ortho-Clinical Diagnostics III May-17-2013
12 Ortho-Clinical Diagnostics II Mar-22-2012
13 Ortho-Clinical Diagnostics II Jan-27-2012
14 Roche Diagnostics Corp. II Jan-06-2009
15 Roche Diagnostics Corp. II Dec-29-2007
16 Siemens Healthcare Diagnostics II Sep-15-2014
17 Siemens Healthcare Diagnostics, Inc II Mar-08-2016
18 Siemens Healthcare Diagnostics, Inc II Dec-16-2014
19 Siemens Healthcare Diagnostics, Inc. II Mar-25-2015
20 Siemens Healthcare Diagnostics, Inc. II Sep-30-2014
21 Siemens Healthcare Diagnostics, Inc. II Feb-24-2014
22 Siemens Healthcare Diagnostics, Inc. III Sep-09-2010
23 Siemens Healthcare Diagnostics, Inc. II May-04-2010
24 Siemens Healthcare Diagnostics, Inc. II Feb-26-2010

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