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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunohistochemistry antibody assay, estrogen receptor
Product CodeMYA
Regulation Number 864.1860
Device Class 2


Premarket Reviews
ManufacturerDecision
DAKO DENMARK A/S
  SUBSTANTIALLY EQUIVALENT 1
DAKO NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
LEICA BIOSYSTEMS NEWCASTLE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LEICA BIOSYSTEMS NEWCASTLE LTD
  SUBSTANTIALLY EQUIVALENT 1
VENTANA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 1 1
2017 2 2
2018 1 1
2021 2 2
2023 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Information 2 2
False Negative Result 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 5 5
No Clinical Signs, Symptoms or Conditions 1 1
Breast Cancer 1 1
Fall 1 1
Misdiagnosis 1 1
Injury 1 1
Breast Neoplasm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ventana Medical Systems Inc I Sep-14-2018
2 Ventana Medical Systems Inc II Jul-01-2011
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