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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diazo colorimetry, bilirubin
Regulation Description Bilirubin (total or direct) test system.
Product CodeCIG
Regulation Number 862.1110
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 22 22
2022 26 26
2023 34 34
2024 39 39
2025 53 53
2026 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 78 78
Low Test Results 74 74
Non Reproducible Results 29 29
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Insufficient Information 3 3
Output Problem 2 2
High Readings 2 2
Unable to Obtain Readings 2 2
Device Ingredient or Reagent Problem 1 1
False Negative Result 1 1
Application Program Problem 1 1
Use of Device Problem 1 1
Incorrect Measurement 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 185 185
Hyperbilirubinemia 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, INc. II Sep-21-2023
2 Siemens Healthcare Diagnostics, Inc. II Sep-06-2024
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