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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 test, qualitative, for hla, non-diagnostic
Product CodeMZI
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
IMMUCOR GTI DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
IMMUCOR TRANSPLANT DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ONE LAMBDA, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2016 6 6
2018 21 21
2019 2 2
2020 2 2
2021 4 4
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Off-Label Use 5 5
Computer Software Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Insufficient Information 2 2
Device Operates Differently Than Expected 2 2
Appropriate Term/Code Not Available 2 2
False Positive Result 2 2
Output Problem 1 1
Device Markings/Labelling Problem 1 1
Non Reproducible Results 1 1
Use of Device Problem 1 1
Missing Test Results 1 1
Incorrect Measurement 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 25 25
No Clinical Signs, Symptoms or Conditions 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Information 2 2
Missing Value Reason 2 2
No Code Available 1 1
No Patient Involvement 1 1

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