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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIAZYME LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 3
SEBIA
  SUBSTANTIALLY EQUIVALENT 2
SENTINEL CH. SPA
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 6
THE BINDING SITE GROUP LTD
  SUBSTANTIALLY EQUIVALENT 3
THE BINDING SITE LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2019 4 4
2021 1 1
2022 11 11
2023 3 3
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 15 15
High Test Results 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Insufficient Information 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 The Binding Site Group, Ltd. II Jul-07-2021
2 The Binding Site Group, Ltd. II Feb-01-2021
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