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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 55 55
2017 101 101
2018 103 103
2019 152 152
2020 115 115
2021 178 178

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 275 275
High Test Results 266 266
Low Test Results 60 60
False Negative Result 42 42
Incorrect, Inadequate or Imprecise Resultor Readings 29 29
Incorrect Or Inadequate Test Results 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Non Reproducible Results 7 7
Nonstandard Device 5 5
No Apparent Adverse Event 4 4
High Readings 4 4
Low Readings 2 2
Incorrect Measurement 2 2
Unable to Obtain Readings 1 1
Device Damaged Prior to Use 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 346 346
No Clinical Signs, Symptoms or Conditions 179 179
No Consequences Or Impact To Patient 92 92
No Information 21 21
No Code Available 15 15
Abdominal Pain 15 15
No Patient Involvement 7 7
Misdiagnosis 4 4
Vomiting 4 4
Fever 3 3
Headache 3 3
Pain 3 3
Abscess 2 2
Cyst(s) 2 2
Lupus 2 2
Nausea 2 2
Test Result 2 2
Fibrosis 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Weakness 1 1
Syncope 1 1
Intermenstrual Bleeding 1 1
Fluid Discharge 1 1
Rupture 1 1
Complete Induced Abortion 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Dyskinesia 1 1
Post Operative Wound Infection 1 1
Sleep Dysfunction 1 1
Ectopic Pregnancy 1 1
Edema 1 1
Fall 1 1
Anemia 1 1
Stroke/CVA 1 1
Congestive Heart Failure 1 1
Renal Disease, End Stage 1 1
Sepsis 1 1
Swelling 1 1
Vertigo 1 1
Visual Impairment 1 1
Hyperglycemia 1 1
Unspecified Infection 1 1
Head Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II Dec-22-2018
2 Ortho-Clinical Diagnostics II May-20-2016
3 Siemens Healthcare Diagnostics Inc II Jan-07-2016
4 Tosoh Bioscience Inc II Jun-05-2018
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