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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 radioimmunoassay, free thyroxine
Regulation Description Free thyroxine test system.
Product CodeCEC
Regulation Number 862.1695
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K240273  Access Free T4
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 106 130
2021 96 96
2022 81 81
2023 99 99
2024 276 280
2025 25 27

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 517 542
Low Test Results 71 71
Incorrect, Inadequate or Imprecise Result or Readings 66 66
Non Reproducible Results 53 58
Incorrect Measurement 12 12
False Positive Result 5 5
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Output Problem 2 2
Optical Problem 1 1
Unable to Obtain Readings 1 1
Human-Device Interface Problem 1 1
Appropriate Term/Code Not Available 1 1
High Readings 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 552 558
No Consequences Or Impact To Patient 108 108
Insufficient Information 11 11
No Known Impact Or Consequence To Patient 7 27
Test Result 3 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Polymyositis 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jun-02-2020
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