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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
  1.  K811194  HITACHI 705 AUTOMATIC BLOOD CHEMISTRY
  2.  K820118  ELECTROLYTE ANALYZER ACCESSORY
  3.  K820888  8700 CLINICAL CHEM. ANALYZER
  4.  K843283  BOEHRINGER MANNHEIM DIAGNOSTICS ADAM
  5.  K852133  REFLOTRON SYSTEM
  6.  K854025  HITACHI 704
  7.  K854243  ES 22
  8.  K860647  ES600 IMMUNOASSAY SYSTEM
  9.  K860748  HITACHI 736
  10.  K872494  HITACHI 717 CHEMISTRY ANALYZER
  11.  K901003  BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER
  12.  K901346  ES 300 IMMUNOASSAY SYSTEM
  13.  K921661  BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
  14.  K942364  HITACHI 914 ANALYZER
  15.  K953239  BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
  16.  K961481  ELECSYS 2010 ANALYZER
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 3
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
High test results 2014
Low test results 1900
Incorrect or inadequate test results 1183
Device displays error message 998
Mechanical issue 483
Leak 472
Incorrect or inadequate result 434
No Known Device Problem 223
Fluid leak 197
Nonstandard device or device component 188
False positive result 152
Malfunction 124
Output, low 116
Smoking 89
False negative result 80
Device operates differently than expected 62
Computer software issue 57
Output, high 50
Imprecision 50
High Readings 40
Corrosion 36
Burn of device or device component 28
Precision 25
Use of Device Issue 23
Other (for use when an appropriate device code cannot be identified) 22
Unable to obtain readings 21
Charred 20
No Information 20
Electrical issue 19
No device output 19
Power source issue 17
Device clogged 16
Fire 15
Unknown (for use when the device problem is not known) 15
Melted 14
Device alarm system issue 14
Crack 14
Electrical shorting 13
Valve(s), failure of 12
Incorrect measurement 12
Repair 11
Failure to back-up 11
Device Issue 11
Low readings 9
Probe failure 8
Contamination during use 7
Obstruction within device 7
Spark 7
Component falling 6
Incorrect display 6
Loose or intermittent connection 6
Incorrect software programming calculations 5
Bent 5
Pumping issue 5
Failure to calibrate 5
No code available 4
Fumes or vapors 4
Arcing 4
Aspiration issue 4
Component(s), broken 4
Break 4
Shock, electrical 4
Failure to pump 4
Device emits odor 4
Overheating of device or device component 3
Calibration error 3
Circuit Failure 3
Device Cleaning Issue 3
Calibration issue 3
Computer operating system issue 3
Contamination of device ingredient or reagent 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
Problem with software installation 3
Device handling issue 3
Electro-static discharge 2
Device inoperable 2
Syringe, defective 2
Cut in material 2
Delivery system failure 2
Sharp/jagged/rough/etched/scratched 2
Ambient noise issue 2
Data Issue 2
Material deformation 2
Mechanical jam 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
Replace 2
False reading from device non-compliance 2
Hole in material 2
Filter break(s) 1
Total Device Problems 9518

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 7
Class III 0 0 2 1 1 2 2 2 1 1

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 II Apr-26-2016
65 Ortho-Clinical Diagnostics II Apr-07-2016
66 Ortho-Clinical Diagnostics II Mar-08-2016
67 Ortho-Clinical Diagnostics II Jan-13-2016
68 Ortho-Clinical Diagnostics II Nov-05-2015
69 Ortho-Clinical Diagnostics II Sep-02-2015
70 Ortho-Clinical Diagnostics II Jun-26-2015
71 Ortho-Clinical Diagnostics II Jun-09-2015
72 Ortho-Clinical Diagnostics II Jun-08-2015
73 Ortho-Clinical Diagnostics II Jun-08-2015
74 Ortho-Clinical Diagnostics II Apr-25-2015
75 Ortho-Clinical Diagnostics III Jan-20-2015
76 Ortho-Clinical Diagnostics II Jan-14-2015
77 Ortho-Clinical Diagnostics II Oct-16-2014
78 Ortho-Clinical Diagnostics II Aug-01-2014
79 Ortho-Clinical Diagnostics II Jun-10-2014
80 Ortho-Clinical Diagnostics II Jun-09-2014
81 Ortho-Clinical Diagnostics II Jun-09-2014
82 Ortho-Clinical Diagnostics II Jun-02-2014
83 Ortho-Clinical Diagnostics II Apr-28-2014
84 Ortho-Clinical Diagnostics II Feb-09-2014
85 Ortho-Clinical Diagnostics II Jul-02-2013
86 Ortho-Clinical Diagnostics II Apr-13-2013
87 Ortho-Clinical Diagnostics II Jan-30-2013
88 Ortho-Clinical Diagnostics II Jul-23-2012
89 Ortho-Clinical Diagnostics II Jun-01-2012
90 Ortho-Clinical Diagnostics II Apr-26-2012
91 Ortho-Clinical Diagnostics III Feb-21-2012
92 Ortho-Clinical Diagnostics II Jan-26-2012
93 Ortho-Clinical Diagnostics II Mar-28-2011
94 Ortho-Clinical Diagnostics II Aug-16-2007
95 Radiometer America Inc II Feb-09-2015
96 Radiometer America Inc III Dec-21-2012
97 Roche Diagnostics Corp. II Apr-10-2009
98 Roche Diagnostics Corp. II Mar-24-2009
99 Roche Diagnostics Corp. II Oct-22-2008
100 Roche Diagnostics Corp. II Aug-13-2008
101 Roche Diagnostics Operations, Inc. II Jun-27-2015
102 Roche Diagnostics Operations, Inc. II Jun-14-2014
103 Roche Diagnostics Operations, Inc. II Apr-10-2014
104 Roche Diagnostics Operations, Inc. II Nov-05-2013
105 Roche Diagnostics Operations, Inc. II May-23-2013
106 Roche Diagnostics Operations, Inc. III Jan-18-2013
107 Roche Diagnostics Operations, Inc. II Dec-04-2012
108 Roche Diagnostics Operations, Inc. II Mar-16-2012
109 Roche Diagnostics Operations, Inc. II Nov-30-2011
110 Roche Diagnostics Operations, Inc. II Nov-30-2011
111 Siemens Healthcare Diagnostics II Sep-29-2014
112 Siemens Healthcare Diagnostics II Sep-18-2014
113 Siemens Healthcare Diagnostics II May-13-2014
114 Siemens Healthcare Diagnostics II Mar-22-2007
115 Siemens Healthcare Diagnostics Inc. II Dec-22-2015
116 Siemens Healthcare Diagnostics Inc. II Jun-24-2010
117 Siemens Healthcare Diagnostics, Inc III Nov-14-2014
118 Siemens Healthcare Diagnostics, Inc II Jun-26-2014
119 Siemens Healthcare Diagnostics, Inc. III May-06-2016
120 Siemens Healthcare Diagnostics, Inc. II Feb-04-2016
121 Siemens Healthcare Diagnostics, Inc. II Jul-09-2015
122 Siemens Healthcare Diagnostics, Inc. II May-14-2015
123 Siemens Healthcare Diagnostics, Inc. II Dec-23-2014
124 Siemens Healthcare Diagnostics, Inc. II Dec-20-2014
125 Siemens Healthcare Diagnostics, Inc. II Aug-26-2014
126 Siemens Healthcare Diagnostics, Inc. III Jul-30-2014
127 Siemens Healthcare Diagnostics, Inc. II Jun-25-2014
128 Siemens Healthcare Diagnostics, Inc. II Jun-09-2014
129 Siemens Healthcare Diagnostics, Inc. II Feb-09-2014
130 Siemens Healthcare Diagnostics, Inc. II Jan-28-2014
131 Siemens Healthcare Diagnostics, Inc. II Jan-21-2014
132 Siemens Healthcare Diagnostics, Inc. II Dec-02-2013
133 Siemens Healthcare Diagnostics, Inc. II Aug-26-2013
134 Siemens Healthcare Diagnostics, Inc. III Apr-01-2013
135 Siemens Healthcare Diagnostics, Inc. II Aug-09-2012
136 Siemens Healthcare Diagnostics, Inc. II Apr-25-2012
137 Siemens Healthcare Diagnostics, Inc. II Apr-10-2012
138 Siemens Healthcare Diagnostics, Inc. II Jan-11-2012
139 Siemens Healthcare Diagnostics, Inc. II Oct-19-2011
140 Siemens Healthcare Diagnostics, Inc. II Oct-12-2011
141 Siemens Healthcare Diagnostics, Inc. II Oct-07-2011
142 Siemens Healthcare Diagnostics, Inc. II Aug-19-2011
143 Siemens Healthcare Diagnostics, Inc. II Oct-21-2010
144 Siemens Healthcare Diagnostics, Inc. II Sep-15-2010
145 Siemens Healthcare Diagnostics, Inc. III Aug-02-2010
146 Siemens Healthcare Diagnostics, Inc. II Mar-10-2010
147 Siemens Healthcare Diagnostics, Inc. II Mar-08-2010
148 Siemens Healthcare Diagnostics, Inc. II Mar-05-2010
149 Siemens Healthcare Diagnostics, Inc. II Sep-29-2009
150 Siemens Medical Solutions Diagnostics II May-23-2015
151 Siemens Medical Solutions Diagnostics II Apr-02-2014

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