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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 2341
Low test results 2230
Incorrect or inadequate test results 1276
Device displays error message 1001
Mechanical issue 806
Leak 542
Incorrect or inadequate result 461
No Known Device Problem 429
Fluid leak 254
Nonstandard device or device component 188
False positive result 157
Malfunction 124
Output, low 116
Smoking 100
Device operates differently than expected 93
False negative result 81
Computer software issue 58
Output, high 50
Imprecision 50
High Readings 41
Burn of device or device component 38
Corrosion 36
Charred 34
Electrical issue 32
No Information 32
Device Issue 31
Power source issue 28
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
Melted 18
Fire 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
Incorrect measurement 12
Valve(s), failure of 12
Repair 11
Failure to back-up 11
Spark 10
Low readings 9
Obstruction within device 8
Contamination during use 8
Probe failure 8
Loose or intermittent connection 6
Component falling 6
Incorrect display 6
Arcing 6
Calibration issue 5
Contamination of device ingredient or reagent 5
Delivery system failure 5
Pumping issue 5
Failure to calibrate 5
Device contamination with blood or blood product 5
Bent 5
Incorrect software programming calculations 5
Overheating of device or device component 5
Device handling issue 5
No code available 4
Failure to pump 4
Device emits odor 4
Component(s), broken 4
Break 4
Shock, electrical 4
Aspiration issue 4
Fumes or vapors 4
Computer operating system issue 3
Problem with software installation 3
Infusion or flow issue 3
Wire(s), breakage of 3
Valve(s), defective 3
Structural problem 3
Seal, defective 3
Inappropriate shock 3
Defective component 3
Improper or incorrect procedure or method 3
Calibration error 3
Circuit Failure 3
Device Cleaning Issue 3
False reading from device non-compliance 3
Data Issue 3
Hole in material 2
Replace 2
Parameter calculation error due to software problem 2
Failure to power-up 2
Occlusion within device 2
Blockage within device or device component 2
Material discolored 2
False device output 2
Error or warning message, failure to produce 2
Explode 2
Electro-static discharge 2
Device inoperable 2
Syringe, defective 2
Cut in material 2
Material deformation 2
Total Device Problems 11123

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

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