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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
2021 3920 3945
2022 3998 4008
2023 3783 3929
2024 4221 4459
2025 4468 4469
2026 1529 1529

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 7679 7833
Low Test Results 6958 7106
Non Reproducible Results 4991 5166
Incorrect, Inadequate or Imprecise Result or Readings 3584 3679
False Positive Result 629 634
Incorrect Measurement 624 655
Output Problem 329 357
Mechanical Problem 300 304
Leak/Splash 224 226
False Negative Result 159 163
Smoking 145 145
Insufficient Information 125 125
Erratic Results 77 77
Use of Device Problem 75 75
Suction Problem 75 76
Thermal Decomposition of Device 72 72
Unable to Obtain Readings 70 81
Appropriate Term/Code Not Available 66 68
Infusion or Flow Problem 65 65
Low Readings 59 62
Sparking 57 57
High Readings 54 56
Adverse Event Without Identified Device or Use Problem 52 55
Chemical Problem 47 52
Material Integrity Problem 46 46
No Apparent Adverse Event 41 44
Pumping Problem 36 36
Computer Software Problem 35 36
Mechanical Jam 32 32
Optical Problem 30 30
Device Fell 28 28
Calibration Problem 28 29
Failure to Deliver 27 27
Electrical /Electronic Property Problem 26 26
Contamination 24 24
Fluid/Blood Leak 23 23
Unintended Electrical Shock 23 23
Filling Problem 21 21
Patient Data Problem 20 20
Mechanics Altered 20 20
Pressure Problem 20 20
Failure to Calibrate 20 20
Electrical Power Problem 18 18
Contamination /Decontamination Problem 17 17
Unintended Movement 16 16
Imprecision 16 16
Improper or Incorrect Procedure or Method 16 16
Signal Artifact/Noise 15 15
Fire 13 13
Degraded 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21142 21561
No Consequences Or Impact To Patient 276 276
Insufficient Information 184 185
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 55 56
No Patient Involvement 51 51
No Known Impact Or Consequence To Patient 34 34
Hyponatremia 21 21
Exposure to Body Fluids 21 21
Laceration(s) 19 19
Needle Stick/Puncture 14 14
Electric Shock 9 9
Electrolyte Imbalance 9 9
Abrasion 9 9
Fall 7 7
Eye Injury 6 6
Pain 5 5
Bruise/Contusion 4 4
Bone Fracture(s) 4 4
Chest Pain 4 4
Syncope/Fainting 4 4
Chemical Exposure 3 3
Burn(s) 3 3
Conjunctivitis 3 3
Concussion 3 3
Red Eye(s) 3 3
Damage to Ligament(s) 3 3
Cardiac Enzyme Elevation 3 3
Muscle/Tendon Damage 3 3
Localized Skin Lesion 2 2
Spontaneous Abortion 2 2
Head Injury 2 2
Eye Pain 2 2
Numbness 2 2
Unspecified Eye / Vision Problem 2 2
Dehydration 2 2
Scar Tissue 2 2
Hypernatremia 2 2
Swelling/ Edema 2 2
Respiratory Failure 1 1
Abortion 1 1
Hemorrhage/Bleeding 1 1
Headache 1 1
Myocardial Infarction 1 1
Renal Failure 1 1
Hypoglycemia 1 1
Coma 1 1
Non specific EKG/ECG Changes 1 1
High Blood Pressure/ Hypertension 1 1
Incomplete Induced Abortion 1 1
Nausea 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Dec-18-2025
2 Abbott Laboratories II Jan-09-2024
3 Abbott Laboratories II Dec-22-2023
4 Abbott Laboratories II Nov-19-2021
5 Abbott Laboratories II Sep-14-2021
6 BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. II Feb-25-2025
7 Beckman Coulter Biomedical GmbH II Jul-14-2023
8 Beckman Coulter Inc. II May-15-2025
9 Beckman Coulter Inc. II Apr-25-2025
10 Beckman Coulter Inc. II Apr-03-2025
11 Beckman Coulter Inc. II Sep-30-2021
12 Beckman Coulter Mishima K.K. II Mar-11-2026
13 Beckman Coulter Mishima K.K. II Jun-04-2025
14 Beckman Coulter Mishima K.K. II Aug-21-2024
15 Beckman Coulter Mishima K.K. II Jul-31-2024
16 Beckman Coulter, Inc. II Jan-06-2026
17 Beckman Coulter, Inc. II Dec-09-2025
18 Beckman Coulter, Inc. II Nov-04-2025
19 Beckman Coulter, Inc. II Aug-05-2025
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 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
42 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
43 Ortho-Clinical Diagnostics, INc. II Jan-21-2025
44 Ortho-Clinical Diagnostics, Inc. II Jun-27-2025
45 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
46 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
47 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
48 Ortho-Clinical Diagnostics, Inc. II Dec-13-2023
49 Ortho-Clinical Diagnostics, Inc. II Oct-02-2023
50 Ortho-Clinical Diagnostics, Inc. II May-04-2023
51 Ortho-Clinical Diagnostics, Inc. II Sep-02-2022
52 Ortho-Clinical Diagnostics, Inc. II Jan-07-2021
53 Randox Laboratories Ltd. III May-09-2024
54 Roche Diagnostics Operations, Inc. II Feb-27-2026
55 Roche Diagnostics Operations, Inc. II Aug-11-2022
56 Roche Diagnostics Operations, Inc. II May-24-2021
57 Siemens Healthcare Diagnostics, Inc II Oct-16-2021
58 Siemens Healthcare Diagnostics, Inc. II Jun-25-2025
59 Siemens Healthcare Diagnostics, Inc. II Dec-04-2024
60 Siemens Healthcare Diagnostics, Inc. II Nov-20-2024
61 Siemens Healthcare Diagnostics, Inc. II Jul-05-2023
62 Siemens Healthcare Diagnostics, Inc. II Dec-02-2021
63 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
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