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U.S. Department of Health and Human Services

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 3
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 16
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
DPC
  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 3
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
High test results 2073
Low test results 1965
Incorrect or inadequate test results 1193
Device displays error message 1000
Mechanical issue 600
Leak 518
Incorrect or inadequate result 448
No Known Device Problem 297
Fluid leak 221
Nonstandard device or device component 188
False positive result 152
Malfunction 124
Output, low 116
Smoking 91
False negative result 80
Device operates differently than expected 73
Computer software issue 57
Output, high 50
Imprecision 50
High Readings 41
Corrosion 36
Burn of device or device component 33
Charred 26
Precision 25
No Information 24
Use of Device Issue 23
Other (for use when an appropriate device code cannot be identified) 22
Electrical issue 22
Unable to obtain readings 21
Power source issue 21
No device output 19
Device Issue 18
Fire 16
Device clogged 16
Melted 15
Unknown (for use when the device problem is not known) 15
Electrical shorting 15
Device alarm system issue 14
Crack 14
Incorrect measurement 12
Valve(s), failure of 12
Repair 11
Failure to back-up 11
Low readings 9
Spark 9
Obstruction within device 8
Probe failure 8
Contamination during use 7
Component falling 6
Incorrect display 6
Loose or intermittent connection 6
Incorrect software programming calculations 5
Bent 5
Failure to calibrate 5
Arcing 5
Calibration issue 5
Delivery system failure 5
Pumping issue 5
Aspiration issue 4
Fumes or vapors 4
Component(s), broken 4
Break 4
Shock, electrical 4
Failure to pump 4
Device emits odor 4
No code available 4
Contamination of device ingredient or reagent 4
Device handling issue 3
Overheating of device or device component 3
Calibration error 3
Circuit Failure 3
Device Cleaning Issue 3
Computer operating system issue 3
Problem with software installation 3
Valve(s), defective 3
Seal, defective 3
Structural problem 3
Wire(s), breakage of 3
Inappropriate shock 3
Improper or incorrect procedure or method 3
Electro-static discharge 2
Defective component 2
Device inoperable 2
Syringe, defective 2
Device contamination with blood or blood product 2
Cut in material 2
Misassembled by Users 2
Infusion or flow issue 2
Material deformation 2
Mechanical jam 2
Device ingredient or reagent issue 2
Sharp/jagged/rough/etched/scratched 2
Ambient noise issue 2
Material discolored 2
False device output 2
Error or warning message, failure to produce 2
Explode 2
Parameter calculation error due to software problem 2
Failure to power-up 2
Occlusion within device 2
Total Device Problems 9987

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 1 0 0 0 0 0
Class II 7 7 6 14 14 19 18 27 18 9
Class III 0 0 2 1 1 2 2 2 1 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jul-22-2015
2 Abbott Laboratories II Jun-08-2015
3 Abbott Laboratories III Sep-30-2009
4 Abbott Laboratories III Sep-30-2009
5 Abbott Laboratories II May-27-2009
6 Abbott Laboratories II Sep-19-2008
7 Abbott Laboratories, Inc II Oct-26-2015
8 Abbott Laboratories, Inc II Sep-23-2010
9 Abbott Laboratories, Inc II Apr-09-2010
10 Abbott Laboratories, Inc II Nov-09-2009
11 Abbott Laboratories, Inc II Nov-07-2007
12 Abbott Laboratories, Inc II Jun-19-2007
13 Abbott Laboratories, Inc II May-09-2007
14 Abbott Laboratories, Inc II Feb-07-2007
15 Beckman Coulter Inc II Sep-21-2008
16 Beckman Coulter Inc II Aug-20-2008
17 Beckman Coulter Inc II Aug-20-2008
18 Beckman Coulter Inc II May-24-2008
19 Beckman Coulter Inc. II Nov-06-2014
20 Beckman Coulter Inc. II Sep-23-2014
21 Beckman Coulter Inc. II Jun-09-2014
22 Beckman Coulter Inc. II Feb-16-2014
23 Beckman Coulter Inc. II Dec-16-2013
24 Beckman Coulter Inc. II Nov-14-2013
25 Beckman Coulter Inc. II Nov-05-2013
26 Beckman Coulter Inc. II Aug-02-2013
27 Beckman Coulter Inc. II Jul-31-2013
28 Beckman Coulter Inc. II May-29-2013
29 Beckman Coulter Inc. II Apr-24-2013
30 Beckman Coulter Inc. II Apr-01-2013
31 Beckman Coulter Inc. II Mar-06-2013
32 Beckman Coulter Inc. II Dec-22-2012
33 Beckman Coulter Inc. II Nov-19-2012
34 Beckman Coulter Inc. II Oct-24-2012
35 Beckman Coulter Inc. II Oct-12-2012
36 Beckman Coulter Inc. II Aug-23-2012
37 Beckman Coulter Inc. II Apr-06-2012
38 Beckman Coulter Inc. II Feb-07-2012
39 Beckman Coulter Inc. II Jan-30-2012
40 Beckman Coulter Inc. II Jan-11-2012
41 Beckman Coulter Inc. II Oct-27-2011
42 Beckman Coulter Inc. II Jun-28-2011
43 Beckman Coulter Inc. II Jun-23-2011
44 Beckman Coulter Inc. I May-06-2011
45 Beckman Coulter Inc. II Apr-26-2011
46 Beckman Coulter Inc. II Apr-13-2011
47 Beckman Coulter Inc. II Apr-12-2011
48 Beckman Coulter Inc. II Apr-11-2011
49 Beckman Coulter Inc. II Dec-13-2010
50 Beckman Coulter Inc. II Sep-30-2010
51 Beckman Coulter Inc. II Sep-20-2010
52 Beckman Coulter Inc. I Mar-04-2010
53 Beckman Coulter Inc. II Mar-02-2010
54 Beckman Coulter Inc. II Feb-25-2010
55 Bio-Rad Laboratories, Inc. II Feb-13-2016
56 Dade Behring, Inc. II Jan-13-2009
57 Dade Behring, Inc. II Aug-22-2007
58 Hamilton Co III Oct-21-2011
59 Horiba Instruments Inc II Apr-22-2016
60 Horiba Instruments, Inc dba Horiba Medical II Jan-02-2015
61 Horiba Instruments, Inc dba Horiba Medical II Jan-03-2013
62 Medica Corporation II Oct-18-2010
63 OPTI Medical Systems, Inc II Oct-18-2013
64 Ortho-Clinical Diagnostics III Jul-08-2016
65 Ortho-Clinical Diagnostics II Jun-06-2016
66 Ortho-Clinical Diagnostics II Apr-26-2016
67 Ortho-Clinical Diagnostics II Apr-07-2016
68 Ortho-Clinical Diagnostics II Mar-08-2016
69 Ortho-Clinical Diagnostics II Jan-13-2016
70 Ortho-Clinical Diagnostics II Nov-05-2015
71 Ortho-Clinical Diagnostics II Sep-02-2015
72 Ortho-Clinical Diagnostics II Jun-26-2015
73 Ortho-Clinical Diagnostics II Jun-09-2015
74 Ortho-Clinical Diagnostics II Jun-08-2015
75 Ortho-Clinical Diagnostics II Jun-08-2015
76 Ortho-Clinical Diagnostics II Apr-25-2015
77 Ortho-Clinical Diagnostics III Jan-20-2015
78 Ortho-Clinical Diagnostics II Jan-14-2015
79 Ortho-Clinical Diagnostics II Oct-16-2014
80 Ortho-Clinical Diagnostics II Aug-01-2014
81 Ortho-Clinical Diagnostics II Jun-10-2014
82 Ortho-Clinical Diagnostics II Jun-09-2014
83 Ortho-Clinical Diagnostics II Jun-09-2014
84 Ortho-Clinical Diagnostics II Jun-02-2014
85 Ortho-Clinical Diagnostics II Apr-28-2014
86 Ortho-Clinical Diagnostics II Feb-09-2014
87 Ortho-Clinical Diagnostics II Jul-02-2013
88 Ortho-Clinical Diagnostics II Apr-13-2013
89 Ortho-Clinical Diagnostics II Jan-30-2013
90 Ortho-Clinical Diagnostics II Jul-23-2012
91 Ortho-Clinical Diagnostics II Jun-01-2012
92 Ortho-Clinical Diagnostics II Apr-26-2012
93 Ortho-Clinical Diagnostics III Feb-21-2012
94 Ortho-Clinical Diagnostics II Jan-26-2012
95 Ortho-Clinical Diagnostics II Mar-28-2011
96 Ortho-Clinical Diagnostics II Aug-16-2007
97 Radiometer America Inc II Feb-09-2015
98 Radiometer America Inc III Dec-21-2012
99 Roche Diagnostics Corp. II Apr-10-2009
100 Roche Diagnostics Corp. II Mar-24-2009
101 Roche Diagnostics Corp. II Oct-22-2008
102 Roche Diagnostics Corp. II Aug-13-2008
103 Roche Diagnostics Operations, Inc. II Jun-27-2015
104 Roche Diagnostics Operations, Inc. II Jun-14-2014
105 Roche Diagnostics Operations, Inc. II Apr-10-2014
106 Roche Diagnostics Operations, Inc. II Nov-05-2013
107 Roche Diagnostics Operations, Inc. II May-23-2013
108 Roche Diagnostics Operations, Inc. III Jan-18-2013
109 Roche Diagnostics Operations, Inc. II Dec-04-2012
110 Roche Diagnostics Operations, Inc. II Mar-16-2012
111 Roche Diagnostics Operations, Inc. II Nov-30-2011
112 Roche Diagnostics Operations, Inc. II Nov-30-2011
113 Siemens Healthcare Diagnostics II Sep-29-2014
114 Siemens Healthcare Diagnostics II Sep-18-2014
115 Siemens Healthcare Diagnostics II May-13-2014
116 Siemens Healthcare Diagnostics II Mar-22-2007
117 Siemens Healthcare Diagnostics Inc. II Jun-01-2016
118 Siemens Healthcare Diagnostics Inc. II Dec-22-2015
119 Siemens Healthcare Diagnostics Inc. II Jun-24-2010
120 Siemens Healthcare Diagnostics, Inc III Nov-14-2014
121 Siemens Healthcare Diagnostics, Inc II Jun-26-2014
122 Siemens Healthcare Diagnostics, Inc. III May-06-2016
123 Siemens Healthcare Diagnostics, Inc. II Feb-04-2016
124 Siemens Healthcare Diagnostics, Inc. II Jul-09-2015
125 Siemens Healthcare Diagnostics, Inc. II May-14-2015
126 Siemens Healthcare Diagnostics, Inc. II Dec-23-2014
127 Siemens Healthcare Diagnostics, Inc. II Dec-20-2014
128 Siemens Healthcare Diagnostics, Inc. II Aug-26-2014
129 Siemens Healthcare Diagnostics, Inc. III Jul-30-2014
130 Siemens Healthcare Diagnostics, Inc. II Jun-25-2014
131 Siemens Healthcare Diagnostics, Inc. II Jun-09-2014
132 Siemens Healthcare Diagnostics, Inc. II Feb-09-2014
133 Siemens Healthcare Diagnostics, Inc. II Jan-28-2014
134 Siemens Healthcare Diagnostics, Inc. II Jan-21-2014
135 Siemens Healthcare Diagnostics, Inc. II Dec-02-2013
136 Siemens Healthcare Diagnostics, Inc. II Aug-26-2013
137 Siemens Healthcare Diagnostics, Inc. III Apr-01-2013
138 Siemens Healthcare Diagnostics, Inc. II Aug-09-2012
139 Siemens Healthcare Diagnostics, Inc. II Apr-25-2012
140 Siemens Healthcare Diagnostics, Inc. II Apr-10-2012
141 Siemens Healthcare Diagnostics, Inc. II Jan-11-2012
142 Siemens Healthcare Diagnostics, Inc. II Oct-19-2011
143 Siemens Healthcare Diagnostics, Inc. II Oct-12-2011
144 Siemens Healthcare Diagnostics, Inc. II Oct-07-2011
145 Siemens Healthcare Diagnostics, Inc. II Aug-19-2011
146 Siemens Healthcare Diagnostics, Inc. II Oct-21-2010
147 Siemens Healthcare Diagnostics, Inc. II Sep-15-2010
148 Siemens Healthcare Diagnostics, Inc. III Aug-02-2010
149 Siemens Healthcare Diagnostics, Inc. II Mar-10-2010
150 Siemens Healthcare Diagnostics, Inc. II Mar-08-2010
151 Siemens Healthcare Diagnostics, Inc. II Mar-05-2010
152 Siemens Healthcare Diagnostics, Inc. II Sep-29-2009
153 Siemens Medical Solutions Diagnostics II May-23-2015
154 Siemens Medical Solutions Diagnostics II Apr-02-2014

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