TPLC - Total Product Life Cycle

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Device	system, test, human chorionic gonadotropin
Regulation Description	Human chorionic gonadotropin (HCG) test system.
Product Code	DHA
Regulation Number	862.1155
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	2
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAZYME LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO CLINICAL DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN YHLO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	576	577
High Test Results	328	337
Non Reproducible Results	193	197
Low Test Results	180	184
False Negative Result	72	72
Incorrect, Inadequate or Imprecise Result or Readings	50	51
Incorrect Measurement	31	31
Output Problem	7	7
No Apparent Adverse Event	5	5
Insufficient Information	4	4
Material Integrity Problem	3	3
Chemical Problem	2	2
Device Sensing Problem	2	2
Mechanical Problem	1	1
Erratic Results	1	1
Defective Device	1	1
High Readings	1	1
Unable to Obtain Readings	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Data Problem	1	1
Product Quality Problem	1	1
Low Readings	1	1
Failure to Calibrate	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1131	1146
Abdominal Pain	14	14
Insufficient Information	11	11
Nausea	9	9
Vomiting	6	6
No Known Impact Or Consequence To Patient	4	4
Pain	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Diarrhea	3	3
Anxiety	3	3
Numbness	2	2
Headache	2	2
Decreased Appetite	2	2
Dysphasia	1	1
Ectopic Pregnancy	1	1
Pancreatitis	1	1
Dysuria	1	1
Genital Bleeding	1	1
Memory Loss/Impairment	1	1
Misdiagnosis	1	1
Complete Induced Abortion	1	1
Cyst(s)	1	1
Intermenstrual Bleeding	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Spinal Column Injury	1	1
Chest Pain	1	1
Septic Shock	1	1
Lymphoma	1	1
Cough	1	1
Decreased Respiratory Rate	1	1
Spontaneous Abortion	1	1
Hallucination	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	III	Jan-17-2023
2	Siemens Healthcare Diagnostics, Inc.	II	Apr-28-2022