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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)
Regulation Description Prolactin (lactogen) test system.
Product CodeCFT
Regulation Number 862.1625
Device Class 1

MDR Year MDR Reports MDR Events
2021 23 23
2022 29 29
2023 27 27
2024 25 25
2025 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 98 98
Low Test Results 24 24
Non Reproducible Results 8 8
Incorrect Measurement 8 8
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Insufficient Information 2 2
Leak/Splash 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 124 124
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 1 1

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