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TPLC
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show TPLC since
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2024
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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
BIOMERIEUX SA, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOMERIEUX, INC
SUBSTANTIALLY EQUIVALENT
15
BIOMÉRIEUX, INC
SUBSTANTIALLY EQUIVALENT
1
BIOMERIEUX, INC.
SUBSTANTIALLY EQUIVALENT
15
COPAN WASP S.R.L.
SUBSTANTIALLY EQUIVALENT
2
SELUX DIAGNOSTICS, INC
SUBSTANTIALLY EQUIVALENT
1
SELUX DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
315
315
2020
218
218
2021
232
232
2022
180
180
2023
453
453
2024
104
104
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
1137
1137
False Positive Result
183
183
Mechanical Problem
21
21
Computer Software Problem
19
19
Contamination
18
18
False Negative Result
14
14
Low Test Results
13
13
Device Markings/Labelling Problem
13
13
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
9
9
Output Problem
7
7
Communication or Transmission Problem
5
5
Device Contamination with Chemical or Other Material
4
4
Loss of Data
3
3
Leak/Splash
3
3
Microbial Contamination of Device
3
3
No Device Output
2
2
Electrical /Electronic Property Problem
2
2
Device Ingredient or Reagent Problem
2
2
Patient Data Problem
2
2
Insufficient Information
2
2
Expiration Date Error
2
2
Unable to Obtain Readings
2
2
Application Program Problem
2
2
Decreased Sensitivity
1
1
Sparking
1
1
High Readings
1
1
Smoking
1
1
Data Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Failure to Back-Up
1
1
Cross Reactivity
1
1
Unsealed Device Packaging
1
1
Product Quality Problem
1
1
Incomplete or Missing Packaging
1
1
High Test Results
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Program or Algorithm Execution Failure
1
1
Illegible Information
1
1
Inaccurate Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
925
925
No Known Impact Or Consequence To Patient
409
409
No Consequences Or Impact To Patient
111
111
No Patient Involvement
33
33
Misdiagnosis
15
15
Insufficient Information
15
15
Drug Resistant Bacterial Infection
2
2
Test Result
1
1
Localized Skin Lesion
1
1
Chemical Exposure
1
1
Bacterial Infection
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 Inc
II
Jan-04-2023
5
Biomerieux Inc
II
Mar-25-2021
6
Organon Teknika Inc
II
Feb-27-2019
7
Remel Inc.
II
May-08-2020
8
bioMerieux, Inc.
II
May-11-2022
9
bioMerieux, Inc.
II
Apr-12-2019
10
bioMerieux, Inc.
II
Feb-16-2019
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