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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
Low test results 2697
High test results 2572
Incorrect or inadequate test results 1409
Mechanical issue 1202
Device displays error message 1000
No Known Device Problem 718
Leak 544
Incorrect or inadequate result 415
Fluid leak 258
Nonstandard device or device component 188
False positive result 138
Malfunction 124
Output, low 116
Smoking 109
No Information 95
Device operates differently than expected 84
False negative result 83
Device Issue 68
Computer software issue 59
Output, high 50
Imprecision 50
Burn of device or device component 41
Charred 38
Corrosion 36
Electrical issue 36
High Readings 35
Power source issue 35
Precision 25
Use of Device Issue 24
Other (for use when an appropriate device code cannot be identified) 22
Unable to obtain readings 21
No device output 19
Fire 19
Melted 18
Electrical shorting 18
Device clogged 16
Unknown (for use when the device problem is not known) 15
Device alarm system issue 14
Crack 14
No code available 13
Incorrect measurement 12
Valve(s), failure of 12
Spark 12
Repair 11
Failure to back-up 11
Contamination during use 8
Probe failure 8
Low readings 8
Obstruction within device 8
Incorrect display 7
Component falling 6
Loose or intermittent connection 6
Arcing 6
Contamination of device ingredient or reagent 5
Delivery system failure 5
Pumping issue 5
Failure to calibrate 5
Incorrect software programming calculations 5
Overheating of device or device component 5
Inappropriate shock 5
Bent 5
Device handling issue 5
Data Issue 4
Break 4
Component(s), broken 4
Failure to pump 4
Shock, electrical 4
Device emits odor 4
Device contamination with blood or blood product 4
Improper or incorrect procedure or method 4
Aspiration issue 4
Calibration issue 4
Fumes or vapors 4
Ambient noise issue 3
Problem with software installation 3
Infusion or flow issue 3
Defective component 3
Wire(s), breakage of 3
Valve(s), defective 3
Seal, defective 3
Structural problem 3
Circuit Failure 3
Device Cleaning Issue 3
Calibration error 3
Unintended movement 3
Computer operating system issue 3
Material discolored 2
Error or warning message, failure to produce 2
Explode 2
False device output 2
False reading from device non-compliance 2
Blockage within device or device component 2
Occlusion within device 2
Hole in material 2
Parameter calculation error due to software problem 2
Failure to power-up 2
Replace 2
Cut in material 2
Device inoperable 2
Electro-static discharge 2
Total Device Problems 12709

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 1 0 0 0 0 0 0
Class II 7 7 6 14 14 19 18 27 18 15 7
Class III 0 0 2 1 1 2 2 2 1 2 0

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 Apr-03-2017
20 Beckman Coulter Inc. II Mar-15-2017
21 Beckman Coulter Inc. II Aug-01-2016
22 Beckman Coulter Inc. II Jul-22-2016
23 Beckman Coulter Inc. II Nov-06-2014
24 Beckman Coulter Inc. II Sep-23-2014
25 Beckman Coulter Inc. II Jun-09-2014
26 Beckman Coulter Inc. II Feb-16-2014
27 Beckman Coulter Inc. II Dec-16-2013
28 Beckman Coulter Inc. II Nov-14-2013
29 Beckman Coulter Inc. II Nov-05-2013
30 Beckman Coulter Inc. II Aug-02-2013
31 Beckman Coulter Inc. II Jul-31-2013
32 Beckman Coulter Inc. II May-29-2013
33 Beckman Coulter Inc. II Apr-24-2013
34 Beckman Coulter Inc. II Apr-01-2013
35 Beckman Coulter Inc. II Mar-06-2013
36 Beckman Coulter Inc. II Dec-22-2012
37 Beckman Coulter Inc. II Nov-19-2012
38 Beckman Coulter Inc. II Oct-24-2012
39 Beckman Coulter Inc. II Oct-12-2012
40 Beckman Coulter Inc. II Aug-23-2012
41 Beckman Coulter Inc. II Apr-06-2012
42 Beckman Coulter Inc. II Feb-07-2012
43 Beckman Coulter Inc. II Jan-30-2012
44 Beckman Coulter Inc. II Jan-11-2012
45 Beckman Coulter Inc. II Oct-27-2011
46 Beckman Coulter Inc. II Jun-28-2011
47 Beckman Coulter Inc. II Jun-23-2011
48 Beckman Coulter Inc. I May-06-2011
49 Beckman Coulter Inc. II Apr-26-2011
50 Beckman Coulter Inc. II Apr-13-2011
51 Beckman Coulter Inc. II Apr-12-2011
52 Beckman Coulter Inc. II Apr-11-2011
53 Beckman Coulter Inc. II Dec-13-2010
54 Beckman Coulter Inc. II Sep-30-2010
55 Beckman Coulter Inc. II Sep-20-2010
56 Beckman Coulter Inc. I Mar-04-2010
57 Beckman Coulter Inc. II Mar-02-2010
58 Beckman Coulter Inc. II Feb-25-2010
59 Bio-Rad Laboratories, Inc. II Feb-13-2016
60 Dade Behring, Inc. II Jan-13-2009
61 Dade Behring, Inc. II Aug-22-2007
62 Hamilton Co III Oct-21-2011
63 Horiba Instruments Inc II Apr-22-2016
64 Horiba Instruments, Inc dba Horiba Medical II Jan-02-2015
65 Horiba Instruments, Inc dba Horiba Medical II Jan-03-2013
66 Medica Corporation II Oct-18-2010
67 OPTI Medical Systems, Inc II Oct-18-2013
68 Ortho-Clinical Diagnostics II May-12-2017
69 Ortho-Clinical Diagnostics II Oct-22-2016
70 Ortho-Clinical Diagnostics III Jul-08-2016
71 Ortho-Clinical Diagnostics II Jun-06-2016
72 Ortho-Clinical Diagnostics II Apr-26-2016
73 Ortho-Clinical Diagnostics II Apr-07-2016
74 Ortho-Clinical Diagnostics II Mar-08-2016
75 Ortho-Clinical Diagnostics II Jan-13-2016
76 Ortho-Clinical Diagnostics II Nov-05-2015
77 Ortho-Clinical Diagnostics II Sep-02-2015
78 Ortho-Clinical Diagnostics II Jun-26-2015
79 Ortho-Clinical Diagnostics II Jun-09-2015
80 Ortho-Clinical Diagnostics II Jun-08-2015
81 Ortho-Clinical Diagnostics II Jun-08-2015
82 Ortho-Clinical Diagnostics II Apr-25-2015
83 Ortho-Clinical Diagnostics III Jan-20-2015
84 Ortho-Clinical Diagnostics II Jan-14-2015
85 Ortho-Clinical Diagnostics II Oct-16-2014
86 Ortho-Clinical Diagnostics II Aug-01-2014
87 Ortho-Clinical Diagnostics II Jun-10-2014
88 Ortho-Clinical Diagnostics II Jun-09-2014
89 Ortho-Clinical Diagnostics II Jun-09-2014
90 Ortho-Clinical Diagnostics II Jun-02-2014
91 Ortho-Clinical Diagnostics II Apr-28-2014
92 Ortho-Clinical Diagnostics II Feb-09-2014
93 Ortho-Clinical Diagnostics II Jul-02-2013
94 Ortho-Clinical Diagnostics II Apr-13-2013
95 Ortho-Clinical Diagnostics II Jan-30-2013
96 Ortho-Clinical Diagnostics II Jul-23-2012
97 Ortho-Clinical Diagnostics II Jun-01-2012
98 Ortho-Clinical Diagnostics II Apr-26-2012
99 Ortho-Clinical Diagnostics III Feb-21-2012
100 Ortho-Clinical Diagnostics II Jan-26-2012
101 Ortho-Clinical Diagnostics II Mar-28-2011
102 Ortho-Clinical Diagnostics II Aug-16-2007
103 Radiometer America Inc II Feb-09-2015
104 Radiometer America Inc III Dec-21-2012
105 Roche Diagnostics Corp. II Apr-10-2009
106 Roche Diagnostics Corp. II Mar-24-2009
107 Roche Diagnostics Corp. II Oct-22-2008
108 Roche Diagnostics Corp. II Aug-13-2008
109 Roche Diagnostics Corporation II May-09-2017
110 Roche Diagnostics Operations, Inc. II Nov-10-2016
111 Roche Diagnostics Operations, Inc. II Oct-25-2016
112 Roche Diagnostics Operations, Inc. II Jun-27-2015
113 Roche Diagnostics Operations, Inc. II Jun-14-2014
114 Roche Diagnostics Operations, Inc. II Apr-10-2014
115 Roche Diagnostics Operations, Inc. II Nov-05-2013
116 Roche Diagnostics Operations, Inc. II May-23-2013
117 Roche Diagnostics Operations, Inc. III Jan-18-2013
118 Roche Diagnostics Operations, Inc. II Dec-04-2012
119 Roche Diagnostics Operations, Inc. II Mar-16-2012
120 Roche Diagnostics Operations, Inc. II Nov-30-2011
121 Roche Diagnostics Operations, Inc. II Nov-30-2011
122 Siemens Healthcare Diagnostics II Sep-29-2014
123 Siemens Healthcare Diagnostics II Sep-18-2014
124 Siemens Healthcare Diagnostics II May-13-2014
125 Siemens Healthcare Diagnostics II Mar-22-2007
126 Siemens Healthcare Diagnostics Inc. II Jun-01-2016
127 Siemens Healthcare Diagnostics Inc. II Dec-22-2015
128 Siemens Healthcare Diagnostics Inc. II Jun-24-2010
129 Siemens Healthcare Diagnostics, Inc III Nov-14-2014
130 Siemens Healthcare Diagnostics, Inc II Jun-26-2014
131 Siemens Healthcare Diagnostics, Inc. II Mar-19-2017
132 Siemens Healthcare Diagnostics, Inc. II Feb-23-2017
133 Siemens Healthcare Diagnostics, Inc. II Nov-16-2016
134 Siemens Healthcare Diagnostics, Inc. III May-06-2016
135 Siemens Healthcare Diagnostics, Inc. II Feb-04-2016
136 Siemens Healthcare Diagnostics, Inc. II Jul-09-2015
137 Siemens Healthcare Diagnostics, Inc. II May-14-2015
138 Siemens Healthcare Diagnostics, Inc. II Dec-23-2014
139 Siemens Healthcare Diagnostics, Inc. II Dec-20-2014
140 Siemens Healthcare Diagnostics, Inc. II Aug-26-2014
141 Siemens Healthcare Diagnostics, Inc. III Jul-30-2014
142 Siemens Healthcare Diagnostics, Inc. II Jun-25-2014
143 Siemens Healthcare Diagnostics, Inc. II Jun-09-2014
144 Siemens Healthcare Diagnostics, Inc. II Feb-09-2014
145 Siemens Healthcare Diagnostics, Inc. II Jan-28-2014
146 Siemens Healthcare Diagnostics, Inc. II Jan-21-2014
147 Siemens Healthcare Diagnostics, Inc. II Dec-02-2013
148 Siemens Healthcare Diagnostics, Inc. II Aug-26-2013
149 Siemens Healthcare Diagnostics, Inc. III Apr-01-2013
150 Siemens Healthcare Diagnostics, Inc. II Aug-09-2012
151 Siemens Healthcare Diagnostics, Inc. II Apr-25-2012
152 Siemens Healthcare Diagnostics, Inc. II Apr-10-2012
153 Siemens Healthcare Diagnostics, Inc. II Jan-11-2012
154 Siemens Healthcare Diagnostics, Inc. II Oct-19-2011
155 Siemens Healthcare Diagnostics, Inc. II Oct-12-2011
156 Siemens Healthcare Diagnostics, Inc. II Oct-07-2011
157 Siemens Healthcare Diagnostics, Inc. II Aug-19-2011
158 Siemens Healthcare Diagnostics, Inc. II Oct-21-2010
159 Siemens Healthcare Diagnostics, Inc. II Sep-15-2010
160 Siemens Healthcare Diagnostics, Inc. III Aug-02-2010
161 Siemens Healthcare Diagnostics, Inc. II Mar-10-2010
162 Siemens Healthcare Diagnostics, Inc. II Mar-08-2010
163 Siemens Healthcare Diagnostics, Inc. II Mar-05-2010
164 Siemens Healthcare Diagnostics, Inc. II Sep-29-2009
165 Siemens Medical Solutions Diagnostics II May-23-2015
166 Siemens Medical Solutions Diagnostics II Apr-02-2014
167 The Binding Site Group, Ltd. II Jan-13-2017

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