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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
2018 27 27
2019 12 12
2020 20 20
2021 23 23
2022 30 30
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 85 85
Low Test Results 28 28
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Incorrect Or Inadequate Test Results 5 5
Incorrect Measurement 4 4
Leak/Splash 1 1
Separation Failure 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 63 63
No Known Impact Or Consequence To Patient 35 35
No Consequences Or Impact To Patient 23 23

Recalls
Manufacturer Recall Class Date Posted
1 Ortho Clinical Diagnostics Inc II Oct-03-2018
2 Ortho-Clinical Diagnostics, Inc II May-18-2022
3 Tosoh Bioscience Inc II Jun-05-2018
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