Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
BIO-RAD LABORATORIES
SUBSTANTIALLY EQUIVALENT
2
DIAZYME LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
FUJIREBIO DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
IMMUNODIAGNOSTIC SYSTEMS LTD
SUBSTANTIALLY EQUIVALENT
1
IMMUNODIAGNOSTIC SYSTEMS LTD.
SUBSTANTIALLY EQUIVALENT
1
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
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
TOSOH BIOSCIENCE, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
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
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
150
150
Non Reproducible Results
52
52
Low Test Results
25
25
Incorrect Or Inadequate Test Results
17
17
Adverse Event Without Identified Device or Use Problem
15
15
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Incorrect Measurement
5
5
High Readings
3
3
Low Readings
3
3
Unable to Obtain Readings
2
2
Device Damaged Prior to Use
2
2
Material Integrity Problem
2
2
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Degraded
1
1
Chemical Problem
1
1
Device Ingredient or Reagent Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
104
104
No Known Impact Or Consequence To Patient
73
73
No Clinical Signs, Symptoms or Conditions
56
56
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
-
-