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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device system, test, thyroglobulin
Product CodeMSW
Regulation Number 866.6010
Device Class 2

MDR Year MDR Reports MDR Events
2018 5 5
2019 2 2
2022 57 57
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 59 59
Low Test Results 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Scratched Material 1 1
Sharp Edges 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 60 60
No Known Impact Or Consequence To Patient 4 4
Myocardial Contusion 2 2
Injury 2 2
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jun-02-2020
2 Siemens Healthcare Diagnostics, Inc. II Jan-11-2023
3 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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