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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
BIOFORTUNA LTD
  SUBSTANTIALLY EQUIVALENT 1
GEN-PROBE
  SUBSTANTIALLY EQUIVALENT 2
GEN-PROBE GTI DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
GENETIC TESTING INSTITUTE, INC. (GTI)
  SUBSTANTIALLY EQUIVALENT 1
IMMUCOR GTI DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 9
IMMUCOR TRANSPLANT DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFE TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLERUP SSP AB
  SUBSTANTIALLY EQUIVALENT 2
ONE LAMBDA, INC
  SUBSTANTIALLY EQUIVALENT 4
ONE LAMBDA, INC.
  SUBSTANTIALLY EQUIVALENT 6
TEPNEL LIFECODES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TEXAS BIOGENE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 209 209
2015 97 97
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
Device Operates Differently Than Expected 119 119
Nonstandard Device 94 94
Incorrect Or Inadequate Test Results 73 73
Incorrect, Inadequate or Imprecise Result or Readings 70 70
High Test Results 20 20
False Positive Result 11 11
Adverse Event Without Identified Device or Use Problem 11 11
False Negative Result 6 6
High Readings 5 5
Off-Label Use 5 5
Imprecision 3 3
Computer Software Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Device Markings/Labelling Problem 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 2 2
Data Problem 2 2
Filtration Problem 2 2
Device Displays Incorrect Message 1 1
Electrical /Electronic Property Problem 1 1
Incorrect Measurement 1 1
Use of Device Problem 1 1
Missing Test Results 1 1
Non Reproducible Results 1 1
Output Problem 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 196 196
Not Applicable 110 111
No Information 15 15
No Consequences Or Impact To Patient 11 11
No Clinical Signs, Symptoms or Conditions 8 8
Missing Value Reason 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Reintubate 1 1
No Patient Involvement 1 1
No Code Available 1 1

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