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
manual antimicrobial susceptibility test systems
Product Code
JWY
Regulation Number
866.1640
Device Class
2
Premarket Reviews
Manufacturer
Decision
AB BIOMERIEUX
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
4
BIOMERIEUX
SUBSTANTIALLY EQUIVALENT
1
BIOMÉRIEUX
SUBSTANTIALLY EQUIVALENT
1
BIOMÉRIEUX S.A.
SUBSTANTIALLY EQUIVALENT
1
BIOMERIEUX SA
SUBSTANTIALLY EQUIVALENT
9
BIOMERIEUX, INC
SUBSTANTIALLY EQUIVALENT
1
BIOMERIEUX, INC.
SUBSTANTIALLY EQUIVALENT
2
LIOFILCHEM S. R. 1.
SUBSTANTIALLY EQUIVALENT
1
LIOFILCHEM S. R. L.
SUBSTANTIALLY EQUIVALENT
22
LIOFILCHEM S.R.L
SUBSTANTIALLY EQUIVALENT
2
LIOFILCHEM S.R.L.
SUBSTANTIALLY EQUIVALENT
7
THERMO FISHER SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
32
THERMOFISHER SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
1
TREK DIAGNOSTIC SYSTEMS
SUBSTANTIALLY EQUIVALENT
2
TREK DIAGNOSTIC SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
TREK DIAGNOSTIC SYSTEMS, LTD.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
11
11
2016
20
20
2017
9
9
2018
13
13
2019
10
10
2020
20
20
2021
41
41
2022
11
11
2023
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
103
103
Incorrect Or Inadequate Test Results
17
17
Low Test Results
9
9
High Test Results
8
8
Low Readings
3
3
High Readings
2
2
Device Inoperable
2
2
Volume Accuracy Problem
1
1
Insufficient Information
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Component Misassembled
1
1
Protective Measures Problem
1
1
Appropriate Term/Code Not Available
1
1
False Positive Result
1
1
False Reading From Device Non-Compliance
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
58
58
No Known Impact Or Consequence To Patient
53
53
No Patient Involvement
19
19
No Consequences Or Impact To Patient
11
11
Not Applicable
3
3
Insufficient Information
2
2
No Code Available
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Oct-02-2018
2
Beckman Coulter, Inc.
II
Apr-27-2015
3
Beckman Coulter, Inc.
II
Apr-27-2015
4
Beckman Coulter, Inc.
II
Apr-26-2015
5
Becton Dickinson & Co.
II
Dec-23-2015
6
Becton Dickinson & Co.
II
Sep-12-2014
7
Becton Dickinson & Co.
II
Jul-24-2013
8
BioMerieux SA
II
Dec-19-2017
9
BioMerieux SA
II
May-03-2017
10
BioMerieux SA
II
May-03-2017
11
BioMerieux SA
II
Mar-21-2017
12
BioMerieux SA
II
Feb-21-2017
13
BioMerieux SA
II
Jul-01-2015
14
Biomerieux
I
Dec-23-2015
15
Biomerieux
III
Nov-19-2014
16
Biomerieux Inc
II
Jan-04-2023
17
Biomerieux Inc
II
Aug-06-2021
18
Remel Inc
I
Dec-08-2022
19
Remel Inc
II
Mar-04-2022
20
Siemens Healthcare Diagnostics, Inc.
II
May-08-2012
21
Siemens Microscan
II
Feb-04-2009
-
-