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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
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 3 3
2016 5 5
2017 9 9
2018 18 18
2019 14 14
2020 1 1
2021 5 5
2022 1 1
2023 3 3
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 18 18
High Test Results 17 17
Adverse Event Without Identified Device or Use Problem 12 12
Low Test Results 12 12
Off-Label Use 4 4
Non Reproducible Results 4 4
Incorrect Or Inadequate Test Results 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Mechanical Problem 1 1
Contamination /Decontamination Problem 1 1
False Reading From Device Non-Compliance 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 35 35
No Consequences Or Impact To Patient 14 14
No Clinical Signs, Symptoms or Conditions 12 12
No Code Available 2 2
No Information 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Sep-18-2009
2 BioCheck Inc II Mar-11-2011
3 ORTHO-CLINICAL DIAGNOSTICS III Jul-08-2016
4 Tosoh Bioscience Inc II Jun-05-2018
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