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TPLC
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Device
system, test, automated, antimicrobial susceptibility, short incubation
Product Code
LON
Regulation Number
866.1645
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER INC.
SUBSTANTIALLY EQUIVALENT
1
BECTON, DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
2
BECTON, DICKINSON, AND COMPANY
SUBSTANTIALLY EQUIVALENT
1
BECTON,DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
1
BIOMERIEUX, INC
SUBSTANTIALLY EQUIVALENT
12
BIOMÉRIEUX, INC
SUBSTANTIALLY EQUIVALENT
1
BIOMERIEUX, INC.
SUBSTANTIALLY EQUIVALENT
13
COPAN WASP S.R.L.
SUBSTANTIALLY EQUIVALENT
1
SELUX DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
512
512
2019
315
315
2020
218
218
2021
232
232
2022
177
177
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
1050
1050
False Positive Result
182
182
Incorrect Or Inadequate Test Results
66
66
Mechanical Problem
21
21
Computer Software Problem
19
19
Contamination
15
15
False Negative Result
12
12
Low Test Results
11
11
Missing Test Results
11
11
Contamination of Device Ingredient or Reagent
10
10
Use of Device Problem
10
10
Improper or Incorrect Procedure or Method
10
10
Incorrect Measurement
8
8
Output Problem
7
7
Communication or Transmission Problem
5
5
Device Markings/Labelling Problem
4
4
Unable to Obtain Readings
3
3
Data Back-Up Problem
3
3
Failure to Back-Up
3
3
Electrical /Electronic Property Problem
2
2
No Device Output
2
2
Loss of Data
2
2
Application Program Problem
2
2
Expiration Date Error
2
2
Insufficient Information
2
2
Data Problem
1
1
Patient Data Problem
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Program or Algorithm Execution Failure
1
1
Illegible Information
1
1
Inaccurate Information
1
1
Decreased Sensitivity
1
1
Device Displays Incorrect Message
1
1
Sparking
1
1
High Readings
1
1
High Test Results
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Ingredient or Reagent Problem
1
1
Unsealed Device Packaging
1
1
Product Quality Problem
1
1
Smoking
1
1
Cross Reactivity
1
1
Leak/Splash
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
645
645
No Clinical Signs, Symptoms or Conditions
374
374
No Consequences Or Impact To Patient
319
319
No Patient Involvement
95
95
Misdiagnosis
19
19
Insufficient Information
9
9
Drug Resistant Bacterial Infection
2
2
Test Result
1
1
Chemical Exposure
1
1
Death
1
1
Unspecified Infection
1
1
Sepsis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Co.
II
Nov-14-2022
2
Becton Dickinson & Co.
II
Dec-31-2020
3
Becton Dickinson & Co.
II
Feb-23-2019
4
BioMerieux SA
II
Jun-12-2018
5
Biomerieux Inc
II
Jan-04-2023
6
Biomerieux Inc
II
Mar-25-2021
7
Organon Teknika Inc
II
Feb-27-2019
8
Remel Inc.
II
May-08-2020
9
bioMerieux, Inc.
II
May-11-2022
10
bioMerieux, Inc.
II
Apr-12-2019
11
bioMerieux, Inc.
II
Feb-16-2019
12
bioMerieux, Inc.
II
Dec-19-2018
13
bioMerieux, Inc.
II
Dec-17-2018
14
bioMerieux, Inc.
I
Aug-30-2018
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