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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
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 132 132
2019 571 571
2020 114 114
2021 158 158
2022 126 126
2023 98 98

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 710 710
False Negative Result 351 351
Incorrect, Inadequate or Imprecise Result or Readings 53 53
High Test Results 37 37
No Apparent Adverse Event 22 22
Low Test Results 8 8
Adverse Event Without Identified Device or Use Problem 6 6
Non Reproducible Results 5 5
Product Quality Problem 4 4
Unable to Obtain Readings 4 4
Insufficient Information 2 2
Output Problem 1 1
Packaging Problem 1 1
Use of Device Problem 1 1
Incorrect Or Inadequate Test Results 1 1
Display Difficult to Read 1 1
Display or Visual Feedback Problem 1 1
Device Ingredient or Reagent Problem 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 535 535
No Clinical Signs, Symptoms or Conditions 295 295
Insufficient Information 127 127
No Information 111 111
No Known Impact Or Consequence To Patient 102 102
No Code Available 17 17
Ectopic Pregnancy 6 6
Miscarriage 5 5
Pregnancy 3 3
Distress 3 3
Anxiety 2 2
Hormonal Imbalance 2 2
Spontaneous Abortion 2 2
Menstrual Irregularities 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Patient Problem/Medical Problem 2 2
Test Result 1 1
Abdominal Pain 1 1
Cyst(s) 1 1
Dyspnea 1 1
Nausea 1 1
Urinary Tract Infection 1 1
Misdiagnosis 1 1
Dizziness 1 1
No Patient Involvement 1 1
Intermenstrual Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ekla Corporation II Jul-09-2018
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
3 Tosoh Bioscience Inc II Jun-05-2018
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