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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


Premarket Reviews
ManufacturerDecision
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVACHEK BIOTECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 52 52
2020 37 37
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 58 58
No Device Output 45 45
Unsealed Device Packaging 19 19
Display Difficult to Read 14 14
Ambient Temperature Problem 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Unable to Obtain Readings 8 8
Product Quality Problem 6 6
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Unexpected Color 4 4
Labelling, Instructions for Use or Training Problem 3 3
Incorrect Measurement 2 2
High Test Results 2 2
Component Missing 2 2
Insufficient Device Problem Information 2 2
Material Integrity Problem 1 1
Output Problem 1 1
Overheating of Device 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 61 61
No Consequences Or Impact To Patient 52 52
No Known Impact Or Consequence To Patient 42 42
Insufficient Information 14 14
Vomiting 3 3
Elevated ketones/Diabetic Ketoacidosis 2 2
Dizziness 2 2
Fatigue 2 2
Headache 2 2
Nausea 1 1
Injury 1 1
Lethargy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. II Feb-28-2020
2 Cardinal Health Inc. II May-20-2020
3 Changchun Wancheng Bio-Electron Co., Ltd. II Feb-04-2026
4 DFI Co., Ltd. II May-06-2026
5 MEDLINE INDUSTRIES, LP - Northfield II Apr-14-2022
6 Medline Industries Inc II Apr-09-2021
7 Stanbio Laboratory, LP II Dec-06-2023
8 Stanbio Laboratory, LP III Aug-05-2021
9 Universal Meditech Inc. II Oct-23-2023
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