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
instrument for auto reader & interpretation of overnight suscept. systems
Product Code
LRG
Regulation Number
866.1640
Device Class
2
Premarket Reviews
Manufacturer
Decision
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
2
THERMO FISHER SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
2
TREK DIAGNOSTIC SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
TREK DIAGNOSTIC SYSTEMS, LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
31
31
2015
30
30
2016
1
1
2017
1
1
2019
3
3
2020
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
18
18
Product Quality Problem
14
14
Incorrect Or Inadequate Test Results
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Nonstandard Device
7
7
Device Emits Odor
2
2
Break
2
2
Fire
2
2
Smoking
2
2
Device Handling Problem
2
2
Device Misassembled During Manufacturing /Shipping
1
1
Electrical Shorting
1
1
Protective Measures Problem
1
1
Device Operates Differently Than Expected
1
1
Loose or Intermittent Connection
1
1
Improper or Incorrect Procedure or Method
1
1
False Device Output
1
1
Pressure Problem
1
1
Device Slipped
1
1
Leak/Splash
1
1
Output Problem
1
1
Mechanical Problem
1
1
False Negative Result
1
1
Application Program Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Failure to Power Up
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Not Applicable
19
19
No Known Impact Or Consequence To Patient
19
19
No Patient Involvement
18
18
No Information
3
3
No Consequences Or Impact To Patient
3
3
Injury
2
2
No Code Available
1
1
Collagen disease
1
1
Chemical Exposure
1
1
Septic Shock
1
1
Eye Injury
1
1
Reaction
1
1
Urinary Tract Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
May-13-2022
2
Beckman Coulter Inc.
II
Apr-07-2021
3
Beckman Coulter Inc.
II
Dec-23-2020
4
Siemens Healthcare Diagnostics, Inc.
II
Jul-02-2014
-
-