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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
2017 3 3
2018 5 5
2019 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Low Test Results 3 3
High Test Results 1 1
Scratched Material 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
Myocardial Contusion 2 2
Injury 2 2
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 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 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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