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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

MDR Year MDR Reports MDR Events
2020 3984 4453
2021 3920 3920
2022 3999 3999
2023 3795 3796
2024 4243 4243
2025 2140 2141

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 7379 7474
Low Test Results 6820 6952
Non Reproducible Results 4650 4917
Incorrect, Inadequate or Imprecise Result or Readings 4225 4226
False Positive Result 563 563
Incorrect Measurement 524 524
Mechanical Problem 289 289
Output Problem 241 241
Leak/Splash 199 199
False Negative Result 162 162
Smoking 156 156
Insufficient Information 105 105
Use of Device Problem 77 77
Thermal Decomposition of Device 75 75
No Device Output 73 73
Erratic Results 59 59
Sparking 58 58
Appropriate Term/Code Not Available 56 56
Unable to Obtain Readings 55 55
Computer Software Problem 51 51
No Apparent Adverse Event 49 49
High Readings 49 49
Suction Problem 49 49
Low Readings 48 48
Adverse Event Without Identified Device or Use Problem 47 47
Material Integrity Problem 42 42
Chemical Problem 36 36
Infusion or Flow Problem 33 33
Mechanical Jam 30 30
Electrical /Electronic Property Problem 30 30
Optical Problem 29 29
Imprecision 28 28
Device Fell 26 26
Electrical Power Problem 25 25
Calibration Problem 25 25
Fluid/Blood Leak 25 25
Patient Data Problem 22 22
Contamination 21 21
Mechanics Altered 20 20
Unintended Electrical Shock 19 19
Filling Problem 18 18
Failure to Deliver 18 18
Fire 18 18
Improper or Incorrect Procedure or Method 18 18
Pumping Problem 17 17
Unintended Movement 16 16
Failure to Calibrate 16 16
Contamination /Decontamination Problem 14 14
Defective Component 12 12
Signal Artifact/Noise 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17731 17745
No Consequences Or Impact To Patient 2089 2089
No Known Impact Or Consequence To Patient 1278 1540
No Patient Involvement 551 551
Insufficient Information 184 310
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 53 53
No Code Available 26 26
Test Result 19 88
Hyponatremia 18 18
Exposure to Body Fluids 17 17
Laceration(s) 15 15
Needle Stick/Puncture 14 14
Electrolyte Imbalance 9 9
Abrasion 9 9
Fall 7 7
Electric Shock 6 6
Eye Injury 5 5
Pain 5 5
Bruise/Contusion 4 4
Chest Pain 4 4
Injury 4 4
Bone Fracture(s) 4 4
Chemical Exposure 3 3
Misdiagnosis 3 3
Damage to Ligament(s) 3 3
Conjunctivitis 3 3
Concussion 3 3
Death 3 3
Hypernatremia 3 3
Muscle/Tendon Damage 3 3
Localized Skin Lesion 2 2
Cardiac Enzyme Elevation 2 2
Eye Pain 2 2
Burn(s) 2 2
Red Eye(s) 2 2
Unspecified Eye / Vision Problem 2 2
Swelling/ Edema 2 2
Numbness 2 2
Renal Failure 2 2
Scar Tissue 2 2
Dehydration 2 2
Patient Problem/Medical Problem 1 1
Respiratory Failure 1 1
Abortion 1 1
Premature Labor 1 1
Headache 1 1
Hypoglycemia 1 1
Incomplete Induced Abortion 1 1
Missing Value Reason 1 1
Coma 1 1

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 Laboratories II Jan-09-2024
5 Abbott Laboratories II Dec-22-2023
6 Abbott Laboratories II Nov-19-2021
7 Abbott Laboratories II Sep-14-2021
8 Abbott Laboratories, Inc II Apr-06-2020
9 BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. II Feb-25-2025
10 Beckman Coulter Biomedical GmbH II Jul-14-2023
11 Beckman Coulter Biomedical GmbH II Sep-18-2020
12 Beckman Coulter Inc. II May-15-2025
13 Beckman Coulter Inc. II Apr-25-2025
14 Beckman Coulter Inc. II Apr-03-2025
15 Beckman Coulter Inc. II Sep-30-2021
16 Beckman Coulter Inc. II Apr-17-2020
17 Beckman Coulter Mishima K.K. II Jun-04-2025
18 Beckman Coulter Mishima K.K. II Aug-21-2024
19 Beckman Coulter Mishima K.K. II Jul-31-2024
20 Beckman Coulter, Inc. II Jun-20-2025
21 Beckman Coulter, Inc. II Apr-24-2025
22 Beckman Coulter, Inc. II Apr-04-2025
23 Beckman Coulter, Inc. II Mar-17-2025
24 Beckman Coulter, Inc. II Mar-17-2025
25 Beckman Coulter, Inc. II Mar-17-2025
26 Beckman Coulter, Inc. II Mar-12-2025
27 Beckman Coulter, Inc. II Feb-06-2025
28 Beckman Coulter, Inc. II Oct-07-2024
29 Beckman Coulter, Inc. II Sep-19-2024
30 Beckman Coulter, Inc. II Aug-30-2024
31 Beckman Coulter, Inc. II Aug-27-2024
32 Beckman Coulter, Inc. II Aug-09-2024
33 Beckman Coulter, Inc. II Aug-09-2024
34 Beckman Coulter, Inc. II Jul-23-2024
35 Beckman Coulter, Inc. II Jul-03-2024
36 Beckman Coulter, Inc. II Jun-28-2024
37 Beckman Coulter, Inc. II Feb-05-2024
38 Beckman Coulter, Inc. II Oct-12-2023
39 Beckman Coulter, Inc. II Jul-26-2023
40 Beckman Coulter, Inc. II Mar-15-2023
41 Biomerieux Inc II Mar-02-2020
42 Inpeco S.A. II May-05-2020
43 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
44 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
45 Ortho Clinical Diagnostics II Aug-24-2020
46 Ortho Clinical Diagnostics II Jul-01-2020
47 Ortho-Clinical Diagnostics, INc. II Jan-21-2025
48 Ortho-Clinical Diagnostics, Inc. II Jun-27-2025
49 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
50 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
51 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
52 Ortho-Clinical Diagnostics, Inc. II Dec-13-2023
53 Ortho-Clinical Diagnostics, Inc. II Oct-02-2023
54 Ortho-Clinical Diagnostics, Inc. II May-04-2023
55 Ortho-Clinical Diagnostics, Inc. II Sep-02-2022
56 Ortho-Clinical Diagnostics, Inc. II Jan-07-2021
57 Randox Laboratories Ltd. III May-09-2024
58 Randox Laboratories, Limited II Feb-24-2020
59 Roche Diagnostics Operations, Inc. II Aug-11-2022
60 Roche Diagnostics Operations, Inc. II May-24-2021
61 Roche Diagnostics Operations, Inc. II Dec-30-2020
62 Roche Diagnostics Operations, Inc. II Dec-29-2020
63 Siemens Healthcare Diagnostics Inc. II Jun-29-2020
64 Siemens Healthcare Diagnostics, Inc II Oct-16-2021
65 Siemens Healthcare Diagnostics, Inc. II Jun-25-2025
66 Siemens Healthcare Diagnostics, Inc. II Dec-04-2024
67 Siemens Healthcare Diagnostics, Inc. II Nov-20-2024
68 Siemens Healthcare Diagnostics, Inc. II Jul-05-2023
69 Siemens Healthcare Diagnostics, Inc. II Dec-02-2021
70 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
71 Siemens Healthcare Diagnostics, Inc. II Jun-19-2020
72 The Binding Site Group, Ltd. II May-21-2020
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