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TPLC
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show TPLC since
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Device
culture media, antimicrobial susceptibility test, excluding mueller hinton agar
Product Code
JSO
Regulation Number
866.1700
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIO-RAD
SUBSTANTIALLY EQUIVALENT
1
BIOMERIEUX SA
SUBSTANTIALLY EQUIVALENT
1
HARDY DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
REMEL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
43
43
2018
14
14
2019
9
9
2020
7
7
2021
27
27
2022
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings
46
46
Incorrect Or Inadequate Test Results
25
25
False Positive Result
21
21
False Negative Result
6
6
Defective Device
3
3
Contamination of Device Ingredient or Reagent
2
2
Contamination
2
2
Material Discolored
1
1
Nonstandard Device
1
1
Device Markings/Labelling Problem
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
42
42
No Clinical Signs, Symptoms or Conditions
25
25
No Consequences Or Impact To Patient
22
22
No Patient Involvement
11
11
Misdiagnosis
4
4
Drug Resistant Bacterial Infection
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Co.
II
Mar-09-2018
2
Becton Dickinson & Co.
II
Dec-06-2017
3
Bio-Rad Laboratories, Inc
II
Jun-06-2019
4
Hardy Diagnostics
II
Jan-25-2021
5
Hardy Diagnostics
II
Jun-09-2020
6
Remel Inc
II
May-12-2021
7
Remel Inc
II
Apr-13-2021
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