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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blood grouping reagent
Regulation Description Blood Grouping Reagent.
Definition For red blood cell antigen typing
Product CodeQHR
Regulation Number 660.20
Device Class Unclassified

MDR Year MDR Reports MDR Events
2021 90 90
2022 64 64
2023 82 82
2024 58 58
2025 28 28
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 171 171
False Negative Result 78 78
Adverse Event Without Identified Device or Use Problem 51 51
Improper or Incorrect Procedure or Method 14 14
Incorrect, Inadequate or Imprecise Result or Readings 11 11
No Apparent Adverse Event 10 10
Output Problem 3 3
Patient Device Interaction Problem 2 2
Off-Label Use 2 2
Appropriate Device Problem Term/Code Not Available 1 1
Short Fill 1 1
Break 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 335 335
Hemolysis 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Laceration(s) 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
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