TPLC - Total Product Life Cycle

show TPLC since

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
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	890	890
False Negative Result	285	285
Incorrect, Inadequate or Imprecise Result or Readings	56	56
High Test Results	38	38
No Apparent Adverse Event	17	17
Low Test Results	11	11
Non Reproducible Results	6	6
Unable to Obtain Readings	5	5
Product Quality Problem	4	4
Display Difficult to Read	1	1
Display or Visual Feedback Problem	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
High Readings	1	1
Device Ingredient or Reagent Problem	1	1
No Flow	1	1
Output Problem	1	1
Packaging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	522	522
No Consequences Or Impact To Patient	433	433
Insufficient Information	141	141
No Information	110	110
No Known Impact Or Consequence To Patient	90	90
Ectopic Pregnancy	6	6
Syncope/Fainting	4	4
No Code Available	4	4
Distress	3	3
Abdominal Pain	2	2
Miscarriage	2	2
Patient Problem/Medical Problem	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Nausea	2	2
Pregnancy	2	2
Anxiety	2	2
Hormonal Imbalance	2	2
Spontaneous Abortion	2	2
Fatigue	1	1
Misdiagnosis	1	1
Dizziness	1	1
Test Result	1	1
Cyst(s)	1	1
Intermenstrual Bleeding	1	1
Pregnancy with a Contraceptive Device	1	1
Dyspnea	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