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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
MDR Year
MDR Reports
MDR Events
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
Unable to Obtain Readings
12
12
Incorrect, Inadequate or Imprecise Result or Readings
12
12
Nonstandard Device
11
11
Low Test Results
7
7
Use of Device Problem
4
4
False Negative Result
3
3
False Positive Result
3
3
Off-Label Use
1
1
Failure to Calibrate
1
1
High Test Results
1
1
High Readings
1
1
Device Markings/Labelling Problem
1
1
Installation-Related Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Non Reproducible Results
1
1
Use of Incorrect Control/Treatment Settings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
39
39
No Known Impact Or Consequence To Patient
12
12
No Consequences Or Impact To Patient
3
3
No Patient Involvement
3
3
Hypersensitivity/Allergic reaction
1
1
Laceration(s)
1
1
No Code Available
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
bioMerieux, Inc.
II
Dec-28-2021
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