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TPLC
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Device
test, epithelial ovarian tumor-associated antigen (ca125)
Product Code
LTK
Regulation Number
866.6010
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER, INC
SUBSTANTIALLY EQUIVALENT
1
BIOMERIEUX, INC.
SUBSTANTIALLY EQUIVALENT
2
FUJIREBIO DIAGNOSTICS, INC
SUBSTANTIALLY EQUIVALENT
1
ORTHO CLINICAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
ROCHE PROFESSIONAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
30
30
2015
11
11
2016
4
4
2017
15
15
2018
8
8
2019
15
15
2020
5
5
2021
2
2
2022
2
2
2023
6
6
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
44
44
Low Test Results
23
23
Adverse Event Without Identified Device or Use Problem
11
11
False Positive Result
10
10
Incorrect Or Inadequate Test Results
5
5
No Apparent Adverse Event
5
5
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Non Reproducible Results
2
2
False Reading From Device Non-Compliance
1
1
High Readings
1
1
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
52
52
No Consequences Or Impact To Patient
30
30
No Clinical Signs, Symptoms or Conditions
12
12
No Code Available
2
2
Test Result
2
2
Misdiagnosis
2
2
Breast Cancer
1
1
Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BioCheck Inc
II
Mar-11-2011
2
Ortho-Clinical Diagnostics
II
Dec-17-2013
3
Siemens Healthcare Diagnostics, Inc
II
Apr-24-2018
4
Siemens Healthcare Diagnostics, Inc
II
Mar-02-2011
5
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
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