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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
Product CodeMSW
Regulation Number 866.6010
Device Class 2


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

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 3 3
2018 5 5
2019 2 2
2022 57 57
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 61 61
Adverse Event Without Identified Device or Use Problem 7 7
Low Test Results 4 4
High Test Results 3 3
Insufficient Information 2 2
Sharp Edges 1 1
Non Reproducible Results 1 1
Scratched Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 62 62
No Known Impact Or Consequence To Patient 9 9
Myocardial Contusion 2 2
Injury 2 2
Misdiagnosis 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jun-02-2020
2 Beckman Coulter Inc. II Jun-28-2017
3 Beckman Coulter Inc. II Sep-03-2015
4 Beckman Coulter Inc. II May-19-2011
5 Beckman Coulter, Inc. II Oct-11-2023
6 Siemens Healthcare Diagnostics, Inc. II Jan-11-2023
7 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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