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TPLC
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Device
system, test, radioallergosorbent (rast) immunological
Product Code
DHB
Regulation Number
866.5750
Device Class
2
Premarket Reviews
Manufacturer
Decision
HITACHI CHEMICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
3
HYCOR BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
4
PHADIA AB
SUBSTANTIALLY EQUIVALENT
15
PHADIA US INC.
SUBSTANTIALLY EQUIVALENT
4
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
6
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
3
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
THERMO FISHER SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2017
11
11
2018
6
6
2019
4
4
2021
7
7
2022
1
1
2023
6
6
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
13
13
Low Test Results
11
11
False Negative Result
11
11
Shipping Damage or Problem
3
3
Device Handling Problem
3
3
Device Markings/Labelling Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
High Test Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
21
21
No Clinical Signs, Symptoms or Conditions
19
19
Nausea
1
1
Dizziness
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hitachi Chemical Diagnostics Inc
III
Feb-07-2013
2
Hycor Biomedical LLC
II
Oct-29-2019
3
Phadia Ab
II
Aug-26-2019
4
Phadia Ab
II
Mar-30-2018
5
Phadia US Inc
II
Apr-05-2018
6
Phadia US Inc
II
Jan-18-2018
7
Phadia US Inc
II
Jan-12-2015
8
Siemens Healthcare Diagnostics, Inc.
II
Dec-15-2022
9
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
10
Siemens Healthcare Diagnostics, Inc.
II
Jun-25-2015
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