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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, follicle-stimulating hormone
Product CodeCGJ
Regulation Number 862.1300
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 3 3
2021 2 2
2022 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3 3
High Test Results 3 3
Premature Separation 2 2
Low Test Results 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Patient Involvement 3 3
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, Inc II May-18-2022
2 Universal Meditech Inc. II Oct-23-2023
3 bioMerieux, Inc. II Dec-28-2021
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