Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 37 37
2024 42 42
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 76 76
Low Test Results 76 76
Non Reproducible Results 14 14
Incorrect, Inadequate or Imprecise Result or Readings 12 12
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 139 139
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
-
-