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TPLC
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Device
diazo colorimetry, bilirubin
Product Code
CIG
Regulation Number
862.1110
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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