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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
ASSURE TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHEMTRON BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ALLTEST BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JAMES NGUYEN
  SUBSTANTIALLY EQUIVALENT 1
NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
POLYMED THERAPEUTICS, INC
  SUBSTANTIALLY EQUIVALENT 2
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
TRUE DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 112 112
2015 134 134
2016 143 143
2017 113 113
2018 132 132
2019 571 571
2020 114 114
2021 158 158
2022 126 126
2023 148 148
2024 169 169

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 891 891
False Negative Result 739 739
Incorrect, Inadequate or Imprecise Result or Readings 143 143
Incorrect Or Inadequate Test Results 65 65
High Test Results 43 43
Adverse Event Without Identified Device or Use Problem 37 37
No Apparent Adverse Event 22 22
Low Test Results 13 13
Non Reproducible Results 6 6
Unable to Obtain Readings 5 5
Insufficient Information 4 4
Product Quality Problem 4 4
False Reading From Device Non-Compliance 2 2
High Readings 2 2
Packaging Problem 1 1
Device Operates Differently Than Expected 1 1
Improper or Incorrect Procedure or Method 1 1
No Flow 1 1
Device Issue 1 1
Display or Visual Feedback Problem 1 1
Device Ingredient or Reagent Problem 1 1
Cut In Material 1 1
No Display/Image 1 1
Output Problem 1 1
Display Difficult to Read 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 791 791
No Clinical Signs, Symptoms or Conditions 502 502
No Known Impact Or Consequence To Patient 290 290
Insufficient Information 134 134
No Information 126 126
No Code Available 31 31
Pregnancy 20 20
Ectopic Pregnancy 12 12
Abdominal Pain 10 10
Miscarriage 7 7
Hemorrhage/Bleeding 6 6
Misdiagnosis 6 6
Patient Problem/Medical Problem 5 5
Syncope/Fainting 4 4
Radiation Exposure, Unintended 4 4
Distress 3 3
Test Result 3 3
Cyst(s) 2 2
Nausea 2 2
No Patient Involvement 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pain 2 2
Anxiety 2 2
Menstrual Irregularities 2 2
Hormonal Imbalance 2 2
Spontaneous Abortion 2 2
Urinary Tract Infection 2 2
Mitral Insufficiency 1 1
Fatigue 1 1
Dizziness 1 1
Blood Loss 1 1
Pyrosis/Heartburn 1 1
Rupture 1 1
Intermenstrual Bleeding 1 1
Pregnancy with a Contraceptive Device 1 1
Electrolyte Imbalance 1 1
Complaint, Ill-Defined 1 1
Discomfort 1 1
Vomiting 1 1
Fall 1 1
Dehydration 1 1
Dyspnea 1 1
Weight Changes 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. II May-25-2013
2 Alere San Diego, Inc. III May-21-2013
3 Beckman Coulter Inc. II Oct-17-2011
4 Beckman Coulter Inc. II Mar-21-2011
5 Ekla Corporation II Jul-09-2018
6 Mainline Technology, Inc. II Jan-15-2009
7 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
8 Quidel Corporation II Mar-01-2011
9 Siemens Healthcare Diagnostics II Feb-07-2012
10 Tosoh Bioscience Inc II Jun-05-2018
11 Universal Meditech Inc. II Oct-23-2023
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