TPLC - Total Product Life Cycle

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Device	system, test, human chorionic gonadotropin
Product Code	DHA
Regulation Number	862.1155
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	3
ABBOTT POINT OF CARE INC.
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIASORIN, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAZYME LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
DIAZYME LABORATORIES INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU WONDFO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN YHLO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	588	588
High Test Results	418	418
Low Test Results	169	169
False Negative Result	88	88
Non Reproducible Results	65	65
Incorrect, Inadequate or Imprecise Result or Readings	55	55
Incorrect Or Inadequate Test Results	29	29
Incorrect Measurement	13	13
Adverse Event Without Identified Device or Use Problem	12	12
Nonstandard Device	5	5
No Apparent Adverse Event	5	5
High Readings	4	4
Low Readings	3	3
Device Displays Incorrect Message	2	2
Output Problem	2	2
Unable to Obtain Readings	2	2
Device Operates Differently Than Expected	1	1
Material Integrity Problem	1	1
Product Quality Problem	1	1
Device Damaged Prior to Use	1	1
Display Difficult to Read	1	1
False Reading From Device Non-Compliance	1	1
Imprecision	1	1
Insufficient Information	1	1
Data Problem	1	1
Device Handling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	633	633
No Known Impact Or Consequence To Patient	429	429
No Consequences Or Impact To Patient	175	175
Abdominal Pain	29	29
No Information	21	21
No Code Available	20	20
Nausea	11	11
Vomiting	10	10
Pain	7	7
No Patient Involvement	7	7
Insufficient Information	6	6
Test Result	5	5
Headache	5	5
Misdiagnosis	4	4
Cyst(s)	3	3
Fever	3	3
Diarrhea	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Decreased Appetite	2	2
Intermenstrual Bleeding	2	2
Numbness	2	2
Ectopic Pregnancy	2	2
Abscess	2	2
Lupus	2	2
Anxiety	2	2
Complaint, Ill-Defined	1	1
Injury	1	1
Dyskinesia	1	1
Dysphasia	1	1
Weakness	1	1
Renal Disease, End Stage	1	1
Sepsis	1	1
Septic Shock	1	1
Spinal Column Injury	1	1
Swelling	1	1
Vertigo	1	1
Visual Impairment	1	1
Memory Loss/Impairment	1	1
Hyperglycemia	1	1
Unspecified Infection	1	1
Head Injury	1	1
Death	1	1
Anemia	1	1
Stroke/CVA	1	1
Chest Pain	1	1
Congestive Heart Failure	1	1
Edema	1	1
Fall	1	1
Post Operative Wound Infection	1	1
Decreased Respiratory Rate	1	1
Sleep Dysfunction	1	1
Dysuria	1	1
Fluid Discharge	1	1
Pregnancy	1	1
Lymphoma	1	1
Hallucination	1	1
Cough	1	1
Pancreatitis	1	1
Genital Bleeding	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Syncope	1	1
Fibrosis	1	1
Rupture	1	1
Complete Induced Abortion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Ireland Diagnostics Division	II	Dec-22-2018
2	Abbott Laboratories	III	Jan-17-2023
3	BioCheck Inc	II	Mar-11-2011
4	Ortho-Clinical Diagnostics	II	May-20-2016
5	Siemens Healthcare Diagnostics Inc	II	Jan-07-2016
6	Siemens Healthcare Diagnostics, Inc.	II	Apr-28-2022
7	Tosoh Bioscience Inc	II	Jun-05-2018