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TPLC
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show TPLC since
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Device
enzyme linked immunoabsorbent assay, rubella
Product Code
LFX
Regulation Number
866.3510
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIO-RAD LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
DIAMEDIX CORP.
SUBSTANTIALLY EQUIVALENT
1
DIASORIN, INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
13
13
2015
15
15
2016
47
47
2017
10
10
2018
24
24
2019
16
16
2020
21
21
2021
13
13
2022
13
13
2023
7
7
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
43
43
Device Ingredient or Reagent Problem
33
33
False Positive Result
29
29
False Negative Result
22
22
Low Test Results
17
17
Incorrect, Inadequate or Imprecise Result or Readings
15
15
Adverse Event Without Identified Device or Use Problem
11
11
No Apparent Adverse Event
11
11
Incorrect Or Inadequate Test Results
6
6
Non Reproducible Results
4
4
Insufficient Information
1
1
Use of Device Problem
1
1
Low Readings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
93
93
No Consequences Or Impact To Patient
49
49
No Clinical Signs, Symptoms or Conditions
37
37
No Patient Involvement
5
5
No Information
1
1
Chemical Exposure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bio-Rad Laboratories
II
May-19-2011
2
Bio-Rad Laboratories
III
Mar-02-2010
3
BioCheck Inc
II
Mar-11-2011
4
Diasorin Inc.
III
Mar-02-2010
5
Meridian Bioscience Inc
II
Nov-17-2011
6
Siemens Healthcare Diagnostics Inc.
II
Mar-10-2010
7
Siemens Healthcare Diagnostics, Inc.
II
Oct-13-2016
8
bioMerieux, Inc.
II
Dec-28-2021
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