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
acid, folic, radioimmunoassay
Product Code
CGN
Regulation Number
862.1295
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
DIASORIN INC.
SUBSTANTIALLY EQUIVALENT
1
DIAZYME LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
3
ROCHE DIAGNOSTICS CORP.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
TOSOH BIOSCIENCE, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
1
1
2016
4
4
2017
6
6
2018
2
2
2019
1
1
2020
5
5
2021
3
3
2022
13
13
2023
9
9
2024
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
20
20
Low Test Results
18
18
Non Reproducible Results
13
13
Incorrect, Inadequate or Imprecise Result or Readings
8
8
Adverse Event Without Identified Device or Use Problem
5
5
Incorrect Measurement
5
5
High Readings
4
4
Failure to Recalibrate
2
2
Incorrect Or Inadequate Test Results
2
2
No Apparent Adverse Event
2
2
Failure to Calibrate
2
2
Device Ingredient or Reagent Problem
1
1
Leak/Splash
1
1
Output Problem
1
1
Off-Label Use
1
1
False Negative Result
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
36
36
No Consequences Or Impact To Patient
10
10
No Known Impact Or Consequence To Patient
9
9
Miscarriage
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Venipuncture
1
1
Chemical Exposure
1
1
Conjunctivitis
1
1
Hyperglycemia
1
1
Hypoglycemia
1
1
Death, Intrauterine Fetal
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
II
Apr-15-2009
2
Baxter Healthcare Corp.
II
Apr-29-2010
3
Beckman Coulter Inc.
II
Oct-10-2012
4
Ortho Clinical Diagnostics Inc
II
Oct-03-2018
5
Ortho-Clinical Diagnostics, Inc.
II
Aug-12-2024
6
Siemens Healthcare Diagnostics
II
Dec-24-2013
7
Siemens Healthcare Diagnostics, Inc
II
Jan-21-2020
8
Siemens Healthcare Diagnostics, Inc
II
Sep-04-2015
9
Siemens Healthcare Diagnostics, Inc
II
May-07-2014
10
Siemens Healthcare Diagnostics, Inc
II
Sep-10-2013
11
Siemens Healthcare Diagnostics, Inc
II
Dec-11-2012
12
Siemens Healthcare Diagnostics, Inc.
II
Feb-21-2023
13
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
14
Tosoh Bioscience Inc
II
Dec-22-2018
-
-