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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, test,alpha-fetoprotein for testicular cancer
Product CodeLOJ
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 14 14
2020 1 1
2021 5 5
2022 1 1
2023 3 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 9 9
High Test Results 8 8
Low Test Results 5 5
Off-Label Use 4 4
Non Reproducible Results 4 4
Incorrect, Inadequate or Imprecise Result or Readings 1 1
False Positive Result 1 1
Mechanical Problem 1 1
Contamination /Decontamination Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
No Known Impact Or Consequence To Patient 9 9
No Consequences Or Impact To Patient 5 5
No Information 1 1
Insufficient Information 1 1

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