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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, hiv detection
Product CodeMZF
Regulation Number 866.3956
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDMIRA LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 154 154
2020 66 66
2021 65 65
2022 115 115
2023 88 88
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 228 228
False Negative Result 205 205
Incorrect, Inadequate or Imprecise Result or Readings 35 35
Non Reproducible Results 15 15
Low Test Results 14 14
Leak/Splash 10 10
Adverse Event Without Identified Device or Use Problem 9 9
No Apparent Adverse Event 6 6
Use of Device Problem 5 5
High Test Results 5 5
Improper or Incorrect Procedure or Method 1 1
Off-Label Use 1 1
Unable to Obtain Readings 1 1
Output Problem 1 1
Illegible Information 1 1
Erratic Results 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 266 266
No Known Impact Or Consequence To Patient 168 168
No Information 63 63
No Consequences Or Impact To Patient 23 23
Insufficient Information 18 18
Pregnancy 13 13
No Code Available 9 9
Exposure to Body Fluids 5 5
Missing Value Reason 3 3
Test Result 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
HIV, Human Immunodeficiency Virus 3 3
Cancer 2 2
Eye Injury 2 2
Hepatitis 2 2
Anxiety 2 2
Needle Stick/Puncture 2 2
Confusion/ Disorientation 2 2
Chemical Exposure 2 2
Viral Infection 1 1

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