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TPLC
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show TPLC since
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Device
visual, pregnancy hcg, prescription use
Product Code
JHI
Regulation Number
862.1155
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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