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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
2019 167 216
2020 106 130
2021 96 96
2022 81 81
2023 99 99
2024 264 268

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 598 659
Low Test Results 88 93
Non Reproducible Results 81 92
Incorrect, Inadequate or Imprecise Result or Readings 70 70
Incorrect Measurement 14 14
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 515 519
No Consequences Or Impact To Patient 244 244
No Known Impact Or Consequence To Patient 35 104
Insufficient Information 11 11
Test Result 3 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
No Patient Involvement 2 2
Polymyositis 1 1

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