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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, vancomycin
Regulation Description Vancomycin test system.
Product CodeLEH
Regulation Number 862.3950
Device Class 2


Premarket Reviews
ManufacturerDecision
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 11 11
2022 7 7
2023 11 11
2024 14 14
2025 15 15
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 45 45
High Test Results 12 12
Non Reproducible Results 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Incorrect Measurement 3 3
Low Readings 2 2
False Positive Result 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
Nausea 1 1
Insufficient Information 1 1
Tachycardia 1 1

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