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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 2

MDR Year MDR Reports MDR Events
2020 31 31
2021 22 22
2022 26 26
2023 34 34
2024 39 39
2025 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 89 89
Low Test Results 82 82
Non Reproducible Results 23 23
Incorrect, Inadequate or Imprecise Result or Readings 16 16
Insufficient Information 3 3
High Readings 2 2
Device Ingredient or Reagent Problem 1 1
False Negative Result 1 1
Output Problem 1 1
Application Program Problem 1 1
Unable to Obtain Readings 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 170 170
No Known Impact Or Consequence To Patient 30 30
No Consequences Or Impact To Patient 2 2
Hyperbilirubinemia 1 1
Test Result 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Mar-02-2020
2 Ortho-Clinical Diagnostics II Aug-24-2020
3 Ortho-Clinical Diagnostics, INc. II Sep-21-2023
4 Siemens Healthcare Diagnostics, Inc. II Sep-06-2024
5 Siemens Healthcare Diagnostics, Inc. II Mar-20-2020
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