TPLC - Total Product Life Cycle

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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

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	776	776
False Negative Result	261	261
Incorrect, Inadequate or Imprecise Result or Readings	52	52
High Test Results	37	37
No Apparent Adverse Event	17	17
Low Test Results	9	9
Non Reproducible Results	5	5
Product Quality Problem	4	4
Unable to Obtain Readings	4	4
Display Difficult to Read	1	1
Display or Visual Feedback Problem	1	1
Device Ingredient or Reagent Problem	1	1
No Flow	1	1
Output Problem	1	1
Packaging Problem	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	433	433
No Clinical Signs, Symptoms or Conditions	390	390
Insufficient Information	127	127
No Information	110	110
No Known Impact Or Consequence To Patient	90	90
Ectopic Pregnancy	6	6
No Code Available	4	4
Distress	3	3
Pregnancy	2	2
Hormonal Imbalance	2	2
Spontaneous Abortion	2	2
Miscarriage	2	2
Anxiety	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Patient Problem/Medical Problem	2	2
Abdominal Pain	1	1
Cyst(s)	1	1
Dyspnea	1	1
Nausea	1	1
Misdiagnosis	1	1
Dizziness	1	1
Intermenstrual Bleeding	1	1
Test Result	1	1

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