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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device method, nephelometric, immunoglobulins (g, a, m)
Product CodeCFN
Regulation Number 866.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE GROUP LTD
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2019 8 8
2022 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 8 8
Low Test Results 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Clinical Signs, Symptoms or Conditions 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Aug-31-2023
2 SIEMENS HEALTHCARE DIAGNOSTICS INC II Oct-14-2022
3 Siemens Healthcare Diagnostics, Inc. II Feb-07-2024
4 The Binding Site Group, Ltd. II Feb-19-2020
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