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TPLC - Total Product Life Cycle
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Device analyzer, chemistry (photometric, discrete), for clinical use
Regulation Description Discrete photometric chemistry analyzer for clinical use.
Product CodeJJE
Regulation Number 862.2160
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 14
BAYER
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 16
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 18
EMD
  SUBSTANTIALLY EQUIVALENT 2
HAMILTON
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 2
LAB-INTERLINK, INC.
  SUBSTANTIALLY EQUIVALENT 1
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
High test results 1610
Low test results 1597
Incorrect or inadequate test results 1063
Device displays error message 981
Leak 330
Incorrect or inadequate result 327
Nonstandard device or device component 185
Malfunction 124
Output, low 116
False positive result 107
Fluid leak 102
Smoking 81
False negative result 70
Computer software issue 52
Output, high 50
Imprecision 48
Corrosion 36
High Readings 32
Precision 25
Other (for use when an appropriate device code cannot be identified) 22
Unable to obtain readings 21
Burn of device or device component 18
No device output 18
Use of Device Issue 18
Device clogged 16
Unknown (for use when the device problem is not known) 15
Device alarm system issue 13
Crack 13
Valve(s), failure of 12
Fire 12
Repair 11
Failure to back-up 11
Melted 11
Incorrect measurement 10
Probe failure 8
Contamination during use 6
Incorrect display 6
Bent 5
Low readings 5
Incorrect software programming calculations 5
Shock, electrical 4
Break 4
No Information 4
Component(s), broken 4
Device operates differently than expected 4
Obstruction within device 4
Fumes or vapors 4
Calibration error 3
Spark 3
Failure to pump 3
Seal, defective 3
Wire(s), breakage of 3
Valve(s), defective 3
Loose or intermittent connection 3
Structural problem 3
Component falling 3
Device emits odor 2
Syringe, defective 2
Parameter calculation error due to software problem 2
False reading from device non-compliance 2
Sharp/jagged/rough/etched/scratched 2
Electrical shorting 2
Ambient noise issue 2
Aspiration issue 2
Error or warning message, failure to produce 2
Cut in material 2
Charred 2
Electro-static discharge 2
Device inoperable 2
Improper or incorrect procedure or method 2
Material deformation 2
Electrical issue 2
Material discolored 2
No Known Device Problem 2
Mechanical issue 2
Replace 2
Explode 2
Data Issue 1
Unintended system motion 1
Device ingredient or reagent issue 1
Tears, rips, holes in device, device material 1
Distilled water, contaminated 1
Fitting problem 1
Power source issue 1
Fuse, blown 1
Hole in material 1
Failure to power-up 1
Defective component 1
Detachment of device component 1
Failure to separate 1
Electrode(s), failure of 1
Tubing, incorrect placement of 1
Device-device incompatibility 1
Output energy incorrect 1
Output issue 1
Cable break 1
Mislabeled 1
Failure to advance 1
Malposition of device 1
Communication or transmission issue 1
Total Device Problems 7312

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 1 1 0 0
Class II 7 7 6 14 14 19 8
Class III 0 0 2 1 1 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III Sep-30-2009
2 Abbott Laboratories III Sep-30-2009
3 Abbott Laboratories II May-27-2009
4 Abbott Laboratories II Sep-19-2008
5 Abbott Laboratories, Inc II Sep-23-2010
6 Abbott Laboratories, Inc II Apr-09-2010
7 Abbott Laboratories, Inc II Nov-09-2009
8 Abbott Laboratories, Inc II Nov-07-2007
9 Abbott Laboratories, Inc II Jun-19-2007
10 Abbott Laboratories, Inc II May-09-2007
11 Abbott Laboratories, Inc II Feb-07-2007
12 Beckman Coulter Inc II Sep-21-2008
13 Beckman Coulter Inc II Aug-20-2008
14 Beckman Coulter Inc II Aug-20-2008
15 Beckman Coulter Inc II May-24-2008
16 Beckman Coulter Inc. II May-29-2013
17 Beckman Coulter Inc. II Apr-24-2013
18 Beckman Coulter Inc. II Apr-01-2013
19 Beckman Coulter Inc. II Mar-06-2013
20 Beckman Coulter Inc. II Dec-22-2012
21 Beckman Coulter Inc. II Nov-19-2012
22 Beckman Coulter Inc. II Oct-24-2012
23 Beckman Coulter Inc. II Oct-12-2012
24 Beckman Coulter Inc. II Aug-23-2012
25 Beckman Coulter Inc. II Apr-06-2012
26 Beckman Coulter Inc. II Feb-07-2012
27 Beckman Coulter Inc. II Jan-30-2012
28 Beckman Coulter Inc. II Jan-11-2012
29 Beckman Coulter Inc. II Oct-27-2011
30 Beckman Coulter Inc. II Jun-28-2011
31 Beckman Coulter Inc. II Jun-23-2011
32 Beckman Coulter Inc. I May-06-2011
33 Beckman Coulter Inc. II Apr-26-2011
34 Beckman Coulter Inc. II Apr-13-2011
35 Beckman Coulter Inc. II Apr-12-2011
36 Beckman Coulter Inc. II Apr-11-2011
37 Beckman Coulter Inc. II Dec-13-2010
38 Beckman Coulter Inc. II Sep-30-2010
39 Beckman Coulter Inc. II Sep-20-2010
40 Beckman Coulter Inc. I Mar-04-2010
41 Beckman Coulter Inc. II Mar-02-2010
42 Beckman Coulter Inc. II Feb-25-2010
43 Dade Behring, Inc. II Jan-13-2009
44 Dade Behring, Inc. II Aug-22-2007
45 Hamilton Co III Oct-21-2011
46 Horiba Instruments, Inc dba Horiba Medical II Jan-03-2013
47 Medica Corporation II Oct-18-2010
48 Ortho-Clinical Diagnostics II Apr-13-2013
49 Ortho-Clinical Diagnostics II Jan-30-2013
50 Ortho-Clinical Diagnostics II Jul-23-2012
51 Ortho-Clinical Diagnostics II Jun-01-2012
52 Ortho-Clinical Diagnostics II Apr-26-2012
53 Ortho-Clinical Diagnostics III Feb-21-2012
54 Ortho-Clinical Diagnostics II Jan-26-2012
55 Ortho-Clinical Diagnostics II Mar-28-2011
56 Ortho-Clinical Diagnostics II Aug-16-2007
57 Radiometer America Inc III Dec-21-2012
58 Roche Diagnostics Corp. II Apr-10-2009
59 Roche Diagnostics Corp. II Mar-24-2009
60 Roche Diagnostics Corp. II Oct-22-2008
61 Roche Diagnostics Corp. II Aug-13-2008
62 Roche Diagnostics Operations, Inc. II May-23-2013
63 Roche Diagnostics Operations, Inc. III Jan-18-2013
64 Roche Diagnostics Operations, Inc. II Dec-04-2012
65 Roche Diagnostics Operations, Inc. II Mar-16-2012
66 Roche Diagnostics Operations, Inc. II Nov-30-2011
67 Roche Diagnostics Operations, Inc. II Nov-30-2011
68 Siemens Healthcare Diagnostics II Mar-22-2007
69 Siemens Healthcare Diagnostics Inc. II Jun-24-2010
70 Siemens Healthcare Diagnostics, Inc. III Apr-01-2013
71 Siemens Healthcare Diagnostics, Inc. II Aug-09-2012
72 Siemens Healthcare Diagnostics, Inc. II Apr-25-2012
73 Siemens Healthcare Diagnostics, Inc. II Apr-10-2012
74 Siemens Healthcare Diagnostics, Inc. II Jan-11-2012
75 Siemens Healthcare Diagnostics, Inc. II Oct-19-2011
76 Siemens Healthcare Diagnostics, Inc. II Oct-12-2011
77 Siemens Healthcare Diagnostics, Inc. II Oct-07-2011
78 Siemens Healthcare Diagnostics, Inc. II Aug-19-2011
79 Siemens Healthcare Diagnostics, Inc. II Oct-21-2010
80 Siemens Healthcare Diagnostics, Inc. II Sep-15-2010
81 Siemens Healthcare Diagnostics, Inc. III Aug-02-2010
82 Siemens Healthcare Diagnostics, Inc. II Mar-10-2010
83 Siemens Healthcare Diagnostics, Inc. II Mar-08-2010
84 Siemens Healthcare Diagnostics, Inc. II Mar-05-2010
85 Siemens Healthcare Diagnostics, Inc. II Sep-29-2009

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