Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Low test results 154
High test results 95
High Readings 77
Calibration error 50
Malfunction 31
Miscalibration 31
Incorrect or inadequate test results 7
Failure to recalibrate 2
Failure to calibrate 1
Mechanical issue 1
Low readings 1
No Known Device Problem 1
Total Device Problems 451

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 0 3 2 0 2 0 7 2 2 1
Class III 2 0 1 1 0 1 1 0 0 0 2

Recalls
Manufacturer Recall Class Date Posted
1 AMS Diagnostics, LLC III Jul-13-2017
2 Abbott Laboratories Inc. II Jun-25-2015
3 Abbott Laboratories Inc. II Feb-06-2009
4 Abbott Laboratories Inc. II Jan-12-2009
5 Beckman Coulter Inc II Jul-13-2017
6 Beckman Coulter Inc. III Oct-22-2012
7 Cargille-Sacher Laboratories Inc. III Dec-01-2009
8 Diagnostic Chemicals, Ltd. III Feb-27-2007
9 Horiba Instruments, Inc dba Horiba Medical II Mar-05-2014
10 Mega Diagnostics III Apr-14-2007
11 Ortho-Clinical Diagnostics II Aug-13-2014
12 Ortho-Clinical Diagnostics II Feb-25-2014
13 Ortho-Clinical Diagnostics III May-17-2013
14 Ortho-Clinical Diagnostics II Mar-22-2012
15 Ortho-Clinical Diagnostics II Jan-27-2012
16 Roche Diagnostics Corp. II Jan-06-2009
17 Roche Diagnostics Corp. II Dec-29-2007
18 Siemens Healthcare Diagnostics II Sep-15-2014
19 Siemens Healthcare Diagnostics, Inc II Mar-08-2016
20 Siemens Healthcare Diagnostics, Inc II Dec-16-2014
21 Siemens Healthcare Diagnostics, Inc. III Feb-16-2017
22 Siemens Healthcare Diagnostics, Inc. II Nov-22-2016
23 Siemens Healthcare Diagnostics, Inc. II Mar-25-2015
24 Siemens Healthcare Diagnostics, Inc. II Sep-30-2014
25 Siemens Healthcare Diagnostics, Inc. II Feb-24-2014
26 Siemens Healthcare Diagnostics, Inc. III Sep-09-2010
27 Siemens Healthcare Diagnostics, Inc. II May-04-2010
28 Siemens Healthcare Diagnostics, Inc. II Feb-26-2010

-
-