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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anti-human globulin
Definition For the performance of direct and indirect antiglobulin tests in blood banking/ immunohematology
Product CodeQHS
Regulation Number 660.50
Device Class Unclassified

MDR Year MDR Reports MDR Events
2018 1 1
2020 15 15
2021 5 5
2022 15 15
2023 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 38 38
Adverse Event Without Identified Device or Use Problem 6 6
False Positive Result 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Defective Device 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
No Known Impact Or Consequence To Patient 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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