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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
  1.  K771345  BICHROMATIC ANALYZER ABA-200
  2.  K782014  ANALYZER ABA-200
  3.  K841916  ABBOTT PROJECT I
  4.  K844114  ADD-1
  5.  K854936  EIA PROCESSOR
  6.  K882913  DTR ANALYZER
  7.  K882914  VISTA INSTRUMENT
  8.  K893776  ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER
  9.  K894222  TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL
  10.  K940289  ABBOTT PRISM ANALYZER
  11.  K945566  ABBOTT PROJECT I, SPECTRUM
  12.  K950915  ABBOTT AXSYM II SYSTEM
  13.  K974651  ABBOTT AXSYM SYSTEM
  14.  K974779  ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300 ...
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 2165
Low test results 2039
Incorrect or inadequate test results 1226
Device displays error message 1000
Mechanical issue 654
Leak 527
Incorrect or inadequate result 452
No Known Device Problem 316
Fluid leak 234
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 77
Computer software issue 57
Output, high 50
Imprecision 50
High Readings 41
Corrosion 36
Burn of device or device component 36
Charred 27
Precision 25
No Information 25
Power source issue 24
Use of Device Issue 24
Electrical issue 24
Other (for use when an appropriate device code cannot be identified) 22
Device Issue 22
Unable to obtain readings 21
No device output 19
Melted 17
Fire 16
Device clogged 16
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
Contamination during use 8
Probe failure 8
Loose or intermittent connection 6
Component falling 6
Incorrect display 6
Bent 5
Incorrect software programming calculations 5
Failure to calibrate 5
Arcing 5
Contamination of device ingredient or reagent 5
Delivery system failure 5
Calibration issue 5
Pumping issue 5
No code available 4
Aspiration issue 4
Fumes or vapors 4
Failure to pump 4
Device emits odor 4
Component(s), broken 4
Break 4
Shock, electrical 4
Calibration error 3
Circuit Failure 3
Device Cleaning Issue 3
Overheating of device or device component 3
Structural problem 3
Valve(s), defective 3
Seal, defective 3
Device contamination with blood or blood product 3
Wire(s), breakage of 3
Inappropriate shock 3
Defective component 3
Improper or incorrect procedure or method 3
Problem with software installation 3
Device handling issue 3
Computer operating system issue 3
Misassembled by Users 2
Output issue 2
Infusion or flow issue 2
Material deformation 2
Mechanical jam 2
Data Issue 2
Ambient noise issue 2
Device ingredient or reagent issue 2
Sharp/jagged/rough/etched/scratched 2
Electro-static discharge 2
Device inoperable 2
Syringe, defective 2
Cut in material 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
Total Device Problems 10310

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

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