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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, vancomycin
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
2019 13 13
2020 14 14
2021 11 11
2022 7 7
2023 11 11
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 40 40
High Test Results 17 17
Low Readings 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Non Reproducible Results 3 3
Erratic Results 1 1
Unexpected Therapeutic Results 1 1
Incorrect Measurement 1 1
Adverse Event Without Identified Device or Use Problem 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34 34
No Known Impact Or Consequence To Patient 15 15
No Consequences Or Impact To Patient 10 10
No Code Available 1 1
Nausea 1 1
Tachycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Oct-04-2019
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