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
1. K203272 Alltest Pregnancy Rapid Combo Test Cassette
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	563	563
False Negative Result	198	198
High Test Results	38	38
Incorrect, Inadequate or Imprecise Result or Readings	34	34
Low Test Results	11	11
Non Reproducible Results	5	5
Unable to Obtain Readings	5	5
Product Quality Problem	4	4
No Apparent Adverse Event	4	4
Device Ingredient or Reagent Problem	1	1
Output Problem	1	1
High Readings	1	1
Use of Device Problem	1	1
Packaging Problem	1	1
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	639	639
Insufficient Information	145	145
No Consequences Or Impact To Patient	38	38
No Known Impact Or Consequence To Patient	21	21
Syncope/Fainting	4	4
Nausea	4	4
No Information	4	4
Abdominal Pain	3	3
Ectopic Pregnancy	3	3
Distress	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Respiratory Tract Infection	2	2
Anxiety	2	2
Cough	2	2
Hormonal Imbalance	2	2
Spontaneous Abortion	2	2
Miscarriage	1	1
Emotional Changes	1	1
Fatigue	1	1
Dizziness	1	1
Cyst(s)	1	1
Intermenstrual Bleeding	1	1
Pregnancy with a Contraceptive Device	1	1
Pregnancy	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