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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, prolactin (lactogen)
Product CodeCFT
Regulation Number 862.1625
Device Class 1

MDR Year MDR Reports MDR Events
2019 12 12
2020 20 20
2021 23 23
2022 29 29
2023 28 28
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 82 82
Low Test Results 29 29
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Incorrect Measurement 5 5
Insufficient Information 2 2
Non Reproducible Results 2 2
Unclear Information 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 85
No Known Impact Or Consequence To Patient 17 17
No Consequences Or Impact To Patient 14 14

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, Inc II May-18-2022
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