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TPLC
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show TPLC since
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Device
system, test, vitamin d
Product Code
MRG
Regulation Number
862.1825
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER INC
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
2
BIO-RAD LABORATORIES
SUBSTANTIALLY EQUIVALENT
2
DIASORIN INC.
SUBSTANTIALLY EQUIVALENT
1
DIAZYME LABORATORIES
SUBSTANTIALLY EQUIVALENT
2
FUJIREBIO DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
IMMUNODIAGNOSTIC SYSTEMS LTD
SUBSTANTIALLY EQUIVALENT
1
IMMUNODIAGNOSTIC SYSTEMS LTD.
SUBSTANTIALLY EQUIVALENT
2
IMMUNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
NANOENTEK USA, INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
2
TOSOH BIOSCIENCE, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
14
14
2015
18
18
2016
14
14
2017
21
21
2018
75
75
2019
38
38
2020
10
10
2021
15
15
2022
13
13
2023
22
22
2024
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
159
159
Non Reproducible Results
55
55
Low Test Results
28
28
Incorrect Or Inadequate Test Results
21
21
Adverse Event Without Identified Device or Use Problem
15
15
Incorrect, Inadequate or Imprecise Result or Readings
11
11
Incorrect Measurement
5
5
High Readings
3
3
Low Readings
3
3
Material Integrity Problem
2
2
Unable to Obtain Readings
2
2
Device Damaged Prior to Use
2
2
Insufficient Information
1
1
Device Ingredient or Reagent Problem
1
1
Chemical Problem
1
1
Degraded
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
109
109
No Known Impact Or Consequence To Patient
82
82
No Clinical Signs, Symptoms or Conditions
60
60
No Patient Involvement
2
2
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Ireland Diagnostics Division
II
Dec-22-2018
2
Qualigen Inc
II
Sep-07-2017
3
R & D Systems, Inc.
III
Nov-09-2018
4
Roche Diagnostics Corporation
II
Jul-08-2018
5
Siemens Healthcare Diagnostics, Inc
II
Nov-11-2016
6
Siemens Healthcare Diagnostics, Inc
II
May-23-2014
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