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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, non-radiolabeled, total thyroxine
Product CodeKLI
Regulation Number 862.1700
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Low Test Results 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Mar-15-2024
2 BioCheck, Inc. II Nov-10-2021
3 DRG International, Inc. II Nov-29-2021
4 Ortho Clinical Diagnostics III Apr-30-2020
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