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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device system, test, human chorionic gonadotropin
Product CodeDHA
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
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 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

MDR Year MDR Reports MDR Events
2019 152 152
2020 115 115
2021 210 210
2022 185 185
2023 199 199
2024 226 226

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 556 556
High Test Results 304 304
Low Test Results 113 113
Non Reproducible Results 99 99
False Negative Result 66 66
Incorrect, Inadequate or Imprecise Result or Readings 45 45
Incorrect Measurement 19 19
No Apparent Adverse Event 5 5
Output Problem 4 4
High Readings 3 3
Low Readings 3 3
Material Integrity Problem 2 2
Unable to Obtain Readings 2 2
Chemical Problem 1 1
Insufficient Information 1 1
Erratic Results 1 1
Data Problem 1 1
Product Quality Problem 1 1
Failure to Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 781 781
No Known Impact Or Consequence To Patient 178 178
No Consequences Or Impact To Patient 43 43
Abdominal Pain 19 19
No Information 14 14
Nausea 10 10
Insufficient Information 8 8
Vomiting 7 7
Pain 6 6
No Patient Involvement 5 5
Headache 4 4
Anxiety 4 4
Misdiagnosis 3 3
Diarrhea 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Code Available 3 3
Decreased Appetite 2 2
Intermenstrual Bleeding 2 2
Test Result 2 2
Ectopic Pregnancy 2 2
Numbness 2 2
Cyst(s) 2 2
Lupus 2 2
Memory Loss/Impairment 1 1
Weakness 1 1
Syncope 1 1
Unspecified Infection 1 1
Decreased Respiratory Rate 1 1
Sleep Dysfunction 1 1
Dyskinesia 1 1
Dysphasia 1 1
Complete Induced Abortion 1 1
Edema 1 1
Fever 1 1
Abscess 1 1
Anemia 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Congestive Heart Failure 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
Dysuria 1 1
Lymphoma 1 1
Hallucination 1 1
Cough 1 1

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