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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nitroprusside, ketones (urinary, non-quant.)
Regulation Description Ketones (nonquantitative) test system.
Product CodeJIN
Regulation Number 862.1435
Device Class 1

MDR Year MDR Reports MDR Events
2021 43 43
2022 14 14
2023 17 17
2024 7 7
2025 4 4
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Discolored 39 39
No Device Output 32 32
Unsealed Device Packaging 18 18
Product Quality Problem 5 5
Unexpected Color 4 4
Labelling, Instructions for Use or Training Problem 3 3
Component Missing 2 2
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Contamination 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 61 61
Insufficient Information 14 14
No Consequences Or Impact To Patient 11 11
Diabetic Ketoacidosis 1 1
Fatigue 1 1
Nausea 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Changchun Wancheng Bio-Electron Co., Ltd. II Feb-04-2026
2 MEDLINE INDUSTRIES, LP - Northfield II Apr-14-2022
3 Medline Industries Inc II Apr-09-2021
4 Stanbio Laboratory, LP II Dec-06-2023
5 Stanbio Laboratory, LP III Aug-05-2021
6 Universal Meditech Inc. II Oct-23-2023
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