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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
Product CodeCIG
Regulation Number 862.1110
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 25 25
2020 31 31
2021 22 22
2022 26 26
2023 37 37
2024 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 86 86
Low Test Results 75 75
Non Reproducible Results 13 13
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Insufficient Information 2 2
Incorrect Measurement 2 2
False Negative Result 1 1
High Readings 1 1
Unable to Obtain Readings 1 1
Use of Device Problem 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120
No Known Impact Or Consequence To Patient 51 51
No Consequences Or Impact To Patient 5 5
No Patient Involvement 1 1
Test Result 1 1
Insufficient Information 1 1
Hyperbilirubinemia 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 Roche Diagnostics Corporation II Apr-13-2019
5 Roche Diagnostics Operations, Inc. III Oct-16-2019
6 Siemens Healthcare Diagnostics, Inc. II Sep-06-2024
7 Siemens Healthcare Diagnostics, Inc. II Mar-20-2020
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