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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device albumin, antigen, antiserum, control
Product CodeDCF
Regulation Number 866.5040
Device Class 2

MDR Year MDR Reports MDR Events
2019 6 6
2020 2 2
2021 3 3
2022 3 3
2023 6 6
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 13 13
Low Test Results 6 6
Non Reproducible Results 2 2
High Readings 1 1
Application Program Problem 1 1
Material Integrity Problem 1 1
Insufficient Information 1 1
Device Alarm System 1 1
Signal Artifact/Noise 1 1
Incorrect Measurement 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 6 6
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Ortho Clinical Diagnostics Inc II Dec-26-2019
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