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TPLC
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Device
fibrinogen and fibrin split products, antigen, antiserum, control
Product Code
DAP
Regulation Number
864.7320
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOMERIEUX, INC.
SUBSTANTIALLY EQUIVALENT
1
DIAGNOSTICA STAGO
SUBSTANTIALLY EQUIVALENT
2
INSTRUMENTATION LABORATORY CO.
SUBSTANTIALLY EQUIVALENT
4
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2014
9
9
2015
38
38
2016
20
20
2017
17
17
2018
5
5
2019
9
9
2020
11
11
2021
7
7
2022
30
30
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
32
32
Unable to Obtain Readings
26
26
Incorrect, Inadequate or Imprecise Result or Readings
14
14
Incorrect Or Inadequate Test Results
13
13
False Positive Result
12
12
Nonstandard Device
11
11
High Test Results
10
10
Adverse Event Without Identified Device or Use Problem
10
10
False Negative Result
5
5
Use of Device Problem
4
4
Off-Label Use
2
2
High Readings
1
1
Use of Incorrect Control/Treatment Settings
1
1
Device Displays Incorrect Message
1
1
Non Reproducible Results
1
1
Device Markings/Labelling Problem
1
1
False Reading From Device Non-Compliance
1
1
Installation-Related Problem
1
1
Failure to Calibrate
1
1
Device Operates Differently Than Expected
1
1
Insufficient Information
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Smoking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
54
54
No Known Impact Or Consequence To Patient
45
45
No Clinical Signs, Symptoms or Conditions
39
39
No Code Available
5
5
No Patient Involvement
3
3
Death
1
1
Hypersensitivity/Allergic reaction
1
1
No Information
1
1
Insufficient Information
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alere San Diego, Inc.
I
Jul-06-2012
2
BioMerieux SA
II
Aug-14-2014
3
Siemens Healthcare Diagnostics Inc
II
Jan-07-2016
4
Siemens Healthcare Diagnostics, Inc.
III
Aug-28-2012
5
bioMerieux, Inc.
II
Dec-28-2021
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