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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
Product CodeJJE
Regulation Number 862.2160
Device Class 1


Premarket Reviews
ManufacturerDecision
CAROLINA LIQUID CHEMISTRIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
HORIBA, LTD
  SUBSTANTIALLY EQUIVALENT 1
JAS DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RANDOX LABORATORIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2840 2840
2015 2793 2793
2016 2580 2667
2017 1869 1869
2018 4590 4590
2019 3947 4504
2020 3984 4453
2021 3920 3920
2022 3999 3999
2023 3795 3796
2024 2713 2713

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 10556 10786
Low Test Results 10081 10387
Non Reproducible Results 5202 5729
Incorrect, Inadequate or Imprecise Result or Readings 4878 4879
Mechanical Problem 1711 1711
Incorrect Or Inadequate Test Results 1597 1671
Adverse Event Without Identified Device or Use Problem 823 823
Leak/Splash 695 695
False Positive Result 667 667
Fluid/Blood Leak 606 606
Patient Data Problem 441 441
Incorrect Measurement 432 432
Smoking 340 340
Device Operates Differently Than Expected 298 298
False Negative Result 226 226
Device Displays Incorrect Message 215 215
Computer Software Problem 186 186
Output Problem 181 181
Nonstandard Device 159 159
Device Issue 157 157
Insufficient Information 153 153
Thermal Decomposition of Device 149 149
No Apparent Adverse Event 141 141
Low Readings 124 124
High Readings 124 124
Use of Device Problem 119 119
Sparking 80 80
Appropriate Term/Code Not Available 79 79
No Device Output 77 77
Unable to Obtain Readings 71 71
Electrical /Electronic Property Problem 70 70
Improper or Incorrect Procedure or Method 67 67
Power Problem 62 62
Calibration Problem 58 58
Erratic Results 56 56
Charred 53 53
Fire 53 53
Device Operational Issue 48 48
Imprecision 48 48
Device Handling Problem 46 46
Device Emits Odor 40 40
Failure to Calibrate 38 38
Mechanical Jam 36 36
Aspiration Issue 35 35
Suction Problem 34 34
False Reading From Device Non-Compliance 34 34
Component Falling 34 34
Defective Component 31 31
Loose or Intermittent Connection 27 27
Optical Problem 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14142 14155
No Known Impact Or Consequence To Patient 11150 12023
No Consequences Or Impact To Patient 9192 9211
No Patient Involvement 1758 1761
No Code Available 159 159
Insufficient Information 131 257
Test Result 84 153
Injury 58 58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
No Information 49 60
Laceration(s) 38 38
Needle Stick/Puncture 23 23
Misdiagnosis 23 23
Exposure to Body Fluids 21 21
Eye Injury 19 19
Hyponatremia 18 18
Not Applicable 18 18
Chemical Exposure 15 15
Electric Shock 14 14
Missing Value Reason 13 13
Patient Problem/Medical Problem 12 12
Death 12 12
Premature Labor 12 12
Abrasion 10 10
Electrolyte Imbalance 9 9
Fall 8 8
Hyperglycemia 6 6
Venipuncture 6 6
Shock 6 6
Pain 6 6
Bone Fracture(s) 5 5
Head Injury 5 5
Headache 5 5
Red Eye(s) 5 5
Nausea 4 4
Chest Pain 4 4
Bruise/Contusion 4 4
Dizziness 3 3
Hemorrhage/Bleeding 3 3
Abortion 3 3
Concussion 3 3
Myocardial Infarction 3 3
Vomiting 3 3
Swelling 3 3
Conjunctivitis 3 3
Muscle/Tendon Damage 3 3
Burn(s) 3 3
Hypoglycemia 2 2
Unspecified Eye / Vision Problem 2 2
Scar Tissue 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Gmbh & Co. KG II Jul-24-2020
2 Abbott Gmbh & Co. KG II Jun-18-2020
3 Abbott Gmbh & Co. KG II Mar-26-2020
4 Abbott Gmbh & Co. KG II Nov-22-2019
5 Abbott Gmbh & Co. KG II Aug-24-2019
6 Abbott Gmbh & Co. KG II Aug-06-2019
7 Abbott Gmbh & Co. KG II Jun-02-2019
8 Abbott Gmbh & Co. KG II May-30-2019
9 Abbott Gmbh & Co. KG II May-13-2019
10 Abbott Gmbh & Co. KG II Apr-18-2019
11 Abbott Gmbh & Co. KG II Jan-30-2019
12 Abbott Laboratories II Jan-09-2024
13 Abbott Laboratories II Dec-22-2023
14 Abbott Laboratories II Nov-19-2021
15 Abbott Laboratories II Sep-14-2021
16 Abbott Laboratories II Jul-22-2015
17 Abbott Laboratories II Jun-08-2015
18 Abbott Laboratories, Inc II Apr-06-2020
19 Abbott Laboratories, Inc II Apr-08-2019
20 Abbott Laboratories, Inc II Jan-18-2018
21 Abbott Laboratories, Inc II Nov-21-2017
22 Abbott Laboratories, Inc II Oct-06-2017
23 Abbott Laboratories, Inc II Oct-26-2015
24 Alere San Diego, Inc. II Sep-05-2019
25 Beckman Coulter Biomedical GmbH II Jul-14-2023
26 Beckman Coulter Biomedical GmbH II Sep-18-2020
27 Beckman Coulter Inc. II Sep-30-2021
28 Beckman Coulter Inc. II Apr-17-2020
29 Beckman Coulter Inc. II Mar-30-2019
30 Beckman Coulter Inc. II Oct-11-2018
31 Beckman Coulter Inc. III Jan-03-2018
32 Beckman Coulter Inc. II Oct-24-2017
33 Beckman Coulter Inc. II Apr-03-2017
34 Beckman Coulter Inc. II Mar-15-2017
35 Beckman Coulter Inc. II Aug-01-2016
36 Beckman Coulter Inc. II Jul-22-2016
37 Beckman Coulter Inc. II Nov-06-2014
38 Beckman Coulter Inc. II Sep-23-2014
39 Beckman Coulter Inc. II Jun-09-2014
40 Beckman Coulter Inc. II Feb-16-2014
41 Beckman Coulter Mishima K.K. II Aug-21-2024
42 Beckman Coulter Mishima K.K. II Jul-31-2024
43 Beckman Coulter, Inc. II Sep-19-2024
44 Beckman Coulter, Inc. II Aug-30-2024
45 Beckman Coulter, Inc. II Aug-27-2024
46 Beckman Coulter, Inc. II Aug-09-2024
47 Beckman Coulter, Inc. II Aug-09-2024
48 Beckman Coulter, Inc. II Jul-23-2024
49 Beckman Coulter, Inc. II Jul-03-2024
50 Beckman Coulter, Inc. II Jun-28-2024
51 Beckman Coulter, Inc. II Feb-05-2024
52 Beckman Coulter, Inc. II Oct-12-2023
53 Beckman Coulter, Inc. II Jul-26-2023
54 Beckman Coulter, Inc. II Mar-15-2023
55 Bio-Rad Laboratories Inc II Jul-25-2018
56 Bio-Rad Laboratories, Inc II Jun-30-2019
57 Bio-Rad Laboratories, Inc. II Feb-13-2016
58 Biomerieux Inc II Mar-02-2020
59 ELITech Group B.V. III Sep-30-2019
60 Horiba Instruments Inc II Apr-22-2016
61 Horiba Instruments, Inc dba Horiba Medical II Jan-31-2018
62 Horiba Instruments, Inc dba Horiba Medical II Jan-02-2015
63 Inova Diagnostics Incorporated II Mar-27-2018
64 Inpeco S.A. II May-05-2020
65 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
66 Ortho Clinical Diagnostics II Aug-24-2020
67 Ortho Clinical Diagnostics II Jul-01-2020
68 Ortho Clinical Diagnostics II Aug-06-2019
69 Ortho-Clinical Diagnostics II Jul-03-2019
70 Ortho-Clinical Diagnostics II May-20-2019
71 Ortho-Clinical Diagnostics II May-06-2019
72 Ortho-Clinical Diagnostics II Apr-25-2019
73 Ortho-Clinical Diagnostics II Dec-20-2018
74 Ortho-Clinical Diagnostics II Dec-14-2017
75 Ortho-Clinical Diagnostics II May-12-2017
76 Ortho-Clinical Diagnostics II Oct-22-2016
77 Ortho-Clinical Diagnostics III Jul-08-2016
78 Ortho-Clinical Diagnostics II Jun-06-2016
79 Ortho-Clinical Diagnostics II Apr-26-2016
80 Ortho-Clinical Diagnostics II Apr-07-2016
81 Ortho-Clinical Diagnostics II Mar-08-2016
82 Ortho-Clinical Diagnostics II Jan-13-2016
83 Ortho-Clinical Diagnostics II Nov-05-2015
84 Ortho-Clinical Diagnostics II Sep-02-2015
85 Ortho-Clinical Diagnostics II Jun-26-2015
86 Ortho-Clinical Diagnostics II Jun-09-2015
87 Ortho-Clinical Diagnostics II Jun-08-2015
88 Ortho-Clinical Diagnostics II Jun-08-2015
89 Ortho-Clinical Diagnostics II Apr-25-2015
90 Ortho-Clinical Diagnostics III Jan-20-2015
91 Ortho-Clinical Diagnostics II Jan-14-2015
92 Ortho-Clinical Diagnostics II Oct-16-2014
93 Ortho-Clinical Diagnostics II Aug-01-2014
94 Ortho-Clinical Diagnostics II Jun-10-2014
95 Ortho-Clinical Diagnostics II Jun-09-2014
96 Ortho-Clinical Diagnostics II Jun-09-2014
97 Ortho-Clinical Diagnostics II Jun-02-2014
98 Ortho-Clinical Diagnostics II Apr-28-2014
99 Ortho-Clinical Diagnostics II Feb-09-2014
100 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
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