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TPLC
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show TPLC since
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2020
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2024
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Device
visual, pregnancy hcg, prescription use
Product Code
JHI
Regulation Number
862.1155
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
High Readings
2
2
False Reading From Device Non-Compliance
2
2
Device Ingredient or Reagent Problem
1
1
Cut In Material
1
1
Output Problem
1
1
No Display/Image
1
1
Use of Device Problem
1
1
Display Difficult to Read
1
1
Device Operates Differently Than Expected
1
1
Packaging Problem
1
1
Display or Visual Feedback Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Device Issue
1
1
No Flow
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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