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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagent red blood cells
Regulation Description Reagent Red Blood Cells.
Definition For the detection of or identification of human blood-group antibodies
Product CodeQHT
Regulation Number 660.30
Device Class Unclassified

MDR Year MDR Reports MDR Events
2021 60 60
2022 48 48
2023 45 45
2024 54 54
2025 51 51
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 179 179
Adverse Event Without Identified Device or Use Problem 38 38
Incorrect, Inadequate or Imprecise Result or Readings 24 24
False Positive Result 15 15
No Apparent Adverse Event 11 11
Off-Label Use 6 6
Erratic Results 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 244 244
Chills 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
Hyperbilirubinemia 1 1
Chest Pain 1 1
Jaundice 1 1

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