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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, thyroglobulin
Regulation Description Tumor-associated antigen immunological test system.
Product CodeMSW
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 57 57
2023 4 4
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 61 61
Non Reproducible Results 3 3
Low Test Results 3 3
Insufficient Information 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65 65

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jun-02-2020
2 Beckman Coulter, Inc. II Oct-11-2023
3 Siemens Healthcare Diagnostics, Inc. II Jan-11-2023
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