TPLC - Total Product Life Cycle

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Device	visual, pregnancy hcg, prescription use
Regulation Description	Human chorionic gonadotropin (HCG) test system.
Product Code	JHI
Regulation Number	862.1155
Device Class	2

Premarket Reviews
Manufacturer	Decision
HANGZHOU ALLTEST BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	763	763
False Negative Result	193	193
Incorrect, Inadequate or Imprecise Result or Readings	35	35
High Test Results	33	33
Low Test Results	10	10
Unable to Obtain Readings	5	5
Non Reproducible Results	4	4
Product Quality Problem	4	4
Device Ingredient or Reagent Problem	1	1
Break	1	1
Output Problem	1	1
No Visual Prompts/Feedback	1	1
Defective Device	1	1
High Readings	1	1
Packaging Problem	1	2
Improper or Incorrect Procedure or Method	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	902	902
Insufficient Information	122	123
Syncope/Fainting	4	4
Nausea	4	4
Anxiety	4	4
Abdominal Pain	3	3
Intermenstrual Bleeding	3	3
Distress	3	3
Ectopic Pregnancy	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Respiratory Tract Infection	2	2
Cough	2	2
Hormonal Imbalance	2	2
Spontaneous Abortion	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Emotional Changes	1	1
Fatigue	1	1
Dizziness	1	1
Cyst(s)	1	1
Pregnancy with a Contraceptive Device	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
2	Princeton Biomeditech Corp	II	Oct-30-2024
3	Universal Meditech Inc.	II	Oct-23-2023