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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lambda, antigen, antiserum, control
Product CodeDEH
Regulation Number 866.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
VENTANA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3 3
2019 8 8
2020 3 3
2021 12 12
2022 7 7
2023 4 4
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 30 30
High Test Results 13 13
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Improper or Incorrect Procedure or Method 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
No Known Impact Or Consequence To Patient 11 11
Renal Failure 2 2

Recalls
Manufacturer Recall Class Date Posted
1 The Binding Site Group, Ltd. II Nov-19-2021
2 The Binding Site Group, Ltd. II Jan-19-2017
3 The Binding Site Group, Ltd. II Jan-19-2017
4 The Binding Site Group, Ltd. II Jan-18-2017
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