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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
assay, glycosylated hemoglobin
Product Code
LCP
Regulation Number
864.7470
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
DRAWBRIDGE HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
1
EKF-DIAGNOSTIC GMBH
SUBSTANTIALLY EQUIVALENT
1
IXENSOR CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
IXENSOR CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
JANA CARE, INC
SUBSTANTIALLY EQUIVALENT
1
SKYLA CORPORATION H.S.P.B.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1908
1908
2019
114
197
2020
13
13
2021
7
8
2022
8
8
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operates Differently Than Expected
621
621
Device Displays Incorrect Message
432
432
Device Operational Issue
359
359
Device Issue
296
296
Mechanical Problem
227
300
Incorrect, Inadequate or Imprecise Result or Readings
132
139
Increase in Pressure
94
94
Incorrect Or Inadequate Test Results
77
77
Pressure Problem
72
72
Decrease in Pressure
63
63
Use of Device Problem
58
58
Leak/Splash
43
43
High Test Results
28
28
Computer Software Problem
18
18
Low Test Results
15
15
Fluid/Blood Leak
14
14
Calibration Problem
13
13
Noise, Audible
13
13
Output Problem
12
12
High Readings
12
12
Failure to Align
9
9
Connection Problem
9
9
Break
9
9
Obstruction of Flow
8
8
Low Readings
8
8
Complete Blockage
7
7
Occlusion Within Device
7
7
Imprecision
7
7
Physical Property Issue
7
7
Non Reproducible Results
6
7
Device Maintenance Issue
6
6
Failure to Calibrate
6
6
No Pressure
6
6
Device Ingredient or Reagent Problem
5
5
Contamination of Device Ingredient or Reagent
5
5
Bent
5
5
Partial Blockage
4
4
Image Resolution Poor
4
4
Fitting Problem
4
4
No Apparent Adverse Event
4
4
Mechanical Jam
4
6
Material Integrity Problem
3
3
Calibration Error
3
3
Detachment Of Device Component
2
2
Fire
2
2
Inaccurate Flow Rate
2
2
No Display/Image
2
2
Poor Quality Image
2
2
Smoking
2
2
Infusion or Flow Problem
2
2
Issue With Displayed Error Message
2
2
Material Deformation
2
2
Loss of Data
2
2
Communication or Transmission Problem
2
2
Computer Operating System Problem
2
2
Data Problem
2
2
Missing Test Results
1
1
Fail-Safe Did Not Operate
1
1
Appropriate Term/Code Not Available
1
1
Power Problem
1
1
Malposition of Device
1
1
Folded
1
1
Date/Time-Related Software Problem
1
1
Material Separation
1
1
Delamination
1
1
Detachment of Device or Device Component
1
1
Device Contamination With Biological Material
1
1
Device Sensing Problem
1
1
Filtration Problem
1
1
Incorrect Error Code
1
1
Material Twisted/Bent
1
1
Operating System Becomes Nonfunctional
1
1
Unable to Obtain Readings
1
2
Failure to Recalibrate
1
1
Difficult to Remove
1
1
Incorrect Measurement
1
1
Loose or Intermittent Connection
1
1
Loss of Power
1
1
Failure to Power Up
1
1
Device Difficult to Setup or Prepare
1
1
Display or Visual Feedback Problem
1
1
Electrical /Electronic Property Problem
1
1
Air Leak
1
1
Device Alarm System
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
1987
2070
No Consequences Or Impact To Patient
29
29
No Clinical Signs, Symptoms or Conditions
18
19
No Information
13
13
Therapeutic Response, Decreased
2
2
Test Result
2
2
No Patient Involvement
1
1
Missing Value Reason
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Polymer Technology Systems
II
Dec-13-2019
2
Siemens Healthcare Diagnostics, Inc.
II
Apr-14-2022
3
Siemens Healthcare Diagnostics, Inc.
II
Jul-31-2020
4
Siemens Healthcare Diagnostics, Inc.
II
Jun-05-2020
5
Tosoh Bioscience Inc
III
Dec-13-2018
6
Tosoh Bioscience Inc
II
Sep-25-2018
7
Tosoh Bioscience Inc
II
Aug-11-2018
8
Tosoh Bioscience Inc
II
May-14-2018
-
-