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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device visual, pregnancy hcg, prescription use
Regulation Description Human chorionic gonadotropin (HCG) test system.
Product CodeJHI
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
HANGZHOU ALLTEST BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 114 114
2021 158 158
2022 126 126
2023 148 148
2024 256 256
2025 172 172

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 656 656
False Negative Result 211 211
Incorrect, Inadequate or Imprecise Result or Readings 38 38
High Test Results 38 38
Low Test Results 11 11
Non Reproducible Results 5 5
Unable to Obtain Readings 5 5
Product Quality Problem 4 4
No Apparent Adverse Event 4 4
Device Ingredient or Reagent Problem 1 1
Break 1 1
Output Problem 1 1
High Readings 1 1
Use of Device Problem 1 1
Packaging Problem 1 1
Improper or Incorrect Procedure or Method 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 747 747
Insufficient Information 145 145
No Consequences Or Impact To Patient 38 38
No Known Impact Or Consequence To Patient 21 21
Syncope/Fainting 4 4
Nausea 4 4
No Information 4 4
Abdominal Pain 3 3
Ectopic Pregnancy 3 3
Distress 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Respiratory Tract Infection 2 2
Anxiety 2 2
Cough 2 2
Hormonal Imbalance 2 2
Spontaneous Abortion 2 2
Miscarriage 1 1
Fatigue 1 1
Emotional Changes 1 1
Dizziness 1 1
Cyst(s) 1 1
Intermenstrual Bleeding 1 1
Pregnancy with a Contraceptive Device 1 1
Pregnancy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
2 Princeton Biomeditech Corp II Oct-30-2024
3 Universal Meditech Inc. II Oct-23-2023
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