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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, free thyroxine
Product CodeCEC
Regulation Number 862.1695
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1
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

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 497 520
Low Test Results 68 68
Incorrect, Inadequate or Imprecise Result or Readings 66 66
Non Reproducible Results 52 57
Incorrect Measurement 12 12
False Positive Result 4 4
Output Problem 2 2
Insufficient Information 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Manufacturing, Packaging or Shipping Problem 1 1
High Readings 1 1
Unable to Obtain Readings 1 1
Optical Problem 1 1
Appropriate Term/Code Not Available 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 527 531
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
No Patient Involvement 1 1
Polymyositis 1 1

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