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TPLC
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show TPLC since
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Device
myoglobin, antigen, antiserum, control
Product Code
DDR
Regulation Number
866.5680
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER, INC
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
DIAZYME LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2016
3
3
2017
5
5
2018
3
3
2019
6
7
2020
2
2
2021
1
1
2022
1
1
2023
7
7
2024
31
31
Device Problems
MDRs with this Device Problem
Events in those MDRs
Product Quality Problem
28
28
Incorrect, Inadequate or Imprecise Result or Readings
25
26
Low Test Results
20
20
Failure to Calibrate
16
16
High Test Results
7
7
Non Reproducible Results
2
2
False Negative Result
2
2
Incorrect Or Inadequate Test Results
1
1
Nonstandard Device
1
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
41
41
No Known Impact Or Consequence To Patient
12
13
No Consequences Or Impact To Patient
6
6
Misdiagnosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
II
Apr-04-2024
2
Abbott Laboratories
II
Apr-15-2009
3
Beckman Coulter Inc
III
May-22-2009
4
Roche Diagnostics Operations, Inc.
II
Aug-30-2019
5
Siemens Healthcare Diagnostics Inc
II
Jan-07-2016
6
Siemens Healthcare Diagnostics, Inc
II
Sep-28-2016
7
Tosoh Bioscience Inc
II
Jun-05-2018
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