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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
2020 20 20
2021 23 23
2022 29 29
2023 28 28
2024 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 94 94
Low Test Results 26 26
Non Reproducible Results 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Incorrect Measurement 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 106 106
No Known Impact Or Consequence To Patient 12 12
No Consequences Or Impact To Patient 7 7

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