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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 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

MDR Year MDR Reports MDR Events
2014 119 119
2015 52 52
2016 55 55
2017 101 101
2018 103 103
2019 152 152
2020 115 115
2021 210 210
2022 185 185
2023 199 199
2024 192 192

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
Material Integrity Problem 2 2
Unable to Obtain Readings 2 2
Device Displays Incorrect Message 2 2
Erratic Results 1 1
Insufficient Information 1 1
Chemical Problem 1 1
Imprecision 1 1
False Reading From Device Non-Compliance 1 1
Data Problem 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Device Operates Differently Than Expected 1 1
Failure to Calibrate 1 1
Display Difficult to Read 1 1
Device Damaged Prior to Use 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
Fever 3 3
Diarrhea 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
Visual Impairment 1 1
Renal Disease, End Stage 1 1
Hyperglycemia 1 1
Fall 1 1
Lymphoma 1 1
Vertigo 1 1
Swelling 1 1
Septic Shock 1 1
Chest Pain 1 1
Pregnancy 1 1
Injury 1 1
Weakness 1 1
Post Operative Wound Infection 1 1
Spinal Column Injury 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Dyskinesia 1 1
Rupture 1 1
Edema 1 1
Anemia 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
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