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
ORTHO CLINICAL DIAGNOSTICS
	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	653	653
High Test Results	446	446
Low Test Results	190	190
Non Reproducible Results	97	97
False Negative Result	91	91
Incorrect, Inadequate or Imprecise Result or Readings	56	56
Incorrect Or Inadequate Test Results	29	29
Incorrect Measurement	19	19
Adverse Event Without Identified Device or Use Problem	12	12
High Readings	5	5
No Apparent Adverse Event	5	5
Nonstandard Device	5	5
Low Readings	4	4
Output Problem	3	3
Unable to Obtain Readings	2	2
Device Displays Incorrect Message	2	2
Material Integrity Problem	2	2
Chemical Problem	1	1
False Reading From Device Non-Compliance	1	1
Imprecision	1	1
Product Quality Problem	1	1
Failure to Calibrate	1	1
Device Operates Differently Than Expected	1	1
Device Damaged Prior to Use	1	1
Display Difficult to Read	1	1
Erratic Results	1	1
Insufficient Information	1	1
Device Handling Problem	1	1
Data Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	747	747
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
Insufficient Information	8	8
Pain	7	7
No Patient Involvement	7	7
Headache	5	5
Test Result	5	5
Anxiety	4	4
Misdiagnosis	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Cyst(s)	3	3
Diarrhea	3	3
Fever	3	3
Decreased Appetite	2	2
Ectopic Pregnancy	2	2
Lupus	2	2
Abscess	2	2
Intermenstrual Bleeding	2	2
Numbness	2	2
Hallucination	1	1
Decreased Respiratory Rate	1	1
Fibrosis	1	1
Cough	1	1
Congestive Heart Failure	1	1
Fluid Discharge	1	1
Renal Disease, End Stage	1	1
Visual Impairment	1	1
Fall	1	1
Hyperglycemia	1	1
Lymphoma	1	1
Chest Pain	1	1
Septic Shock	1	1
Vertigo	1	1
Swelling	1	1
Weakness	1	1
Injury	1	1
Pregnancy	1	1
Spinal Column Injury	1	1
Post Operative Wound Infection	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Edema	1	1
Anemia	1	1
Dyskinesia	1	1
Rupture	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