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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
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
  1.  K000576  ELECSYS CORTISOL CALCHECK
  2.  K011226  CALIBRATOR FOR AUTOMATED SYSTEMS
  3.  K031880  AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CO ...
  4.  K033501  MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS ( ...
  5.  K033873  ELECSYS C-PEPTIDE CALSET
  6.  K040245  CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-C ...
  7.  K040264  CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE ...
  8.  K050026  PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPAT ...
  9.  K062319  CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL ...
  10.  K080607  CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEI ...
  11.  K101456  ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS ...
  12.  K103171  ELECSYS ANTI-TPO CALSET
  13.  K133330  C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLIN ...
  14.  K831030  COBAS STANDARDS FOR GLUCOSE & BUN
  15.  K850396  ROCHE STANDARDS FOR CHLORIDE & CO2
  16.  K850859  COBAS CALIBRATOR SERUM
  17.  K897071  ROCHE STANDARDS FOR THE COBAS ISE MODULE
  18.  K897097  COBAS READY CALIBRATOR KIT
  19.  K914750  ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
  20.  K922043  ROCHE CALIBRATOR SERUM
  21.  K942706  ROCHE CALIBRATOR SERUM
  22.  K952282  ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
  23.  K990460  CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
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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