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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device visual, pregnancy hcg, prescription use
Product CodeJHI
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
HANGZHOU ALLTEST BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 571 571
2020 114 114
2021 158 158
2022 126 126
2023 148 148
2024 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 783 783
False Negative Result 265 265
Incorrect, Inadequate or Imprecise Result or Readings 52 52
High Test Results 37 37
No Apparent Adverse Event 17 17
Low Test Results 10 10
Non Reproducible Results 5 5
Product Quality Problem 4 4
Unable to Obtain Readings 4 4
Display Difficult to Read 1 1
Display or Visual Feedback Problem 1 1
Device Ingredient or Reagent Problem 1 1
No Flow 1 1
Output Problem 1 1
Packaging Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 433 433
No Clinical Signs, Symptoms or Conditions 398 398
Insufficient Information 127 127
No Information 110 110
No Known Impact Or Consequence To Patient 90 90
Ectopic Pregnancy 6 6
No Code Available 4 4
Syncope/Fainting 4 4
Distress 3 3
Hormonal Imbalance 2 2
Spontaneous Abortion 2 2
Pregnancy 2 2
Miscarriage 2 2
Anxiety 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Patient Problem/Medical Problem 2 2
Abdominal Pain 1 1
Cyst(s) 1 1
Dyspnea 1 1
Nausea 1 1
Misdiagnosis 1 1
Dizziness 1 1
Intermenstrual Bleeding 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
2 Universal Meditech Inc. II Oct-23-2023
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