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TPLC
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show TPLC since
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Device
assay, enzyme linked immunosorbent, hepatitis c virus
Product Code
MZO
Device Class
2
Premarket Reviews
Manufacturer
Decision
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
11
12
40
24
16
10
14
19
16
17
11
13
8
0
0
0
MDR Year
MDR Reports
MDR Events
2014
57
57
2015
41
41
2016
115
115
2017
116
116
2018
153
153
2019
138
138
2020
47
47
2021
26
26
2022
56
56
2023
55
55
2024
41
41
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
487
487
Adverse Event Without Identified Device or Use Problem
105
105
Low Test Results
100
100
False Positive Result
52
52
No Apparent Adverse Event
35
35
Incorrect, Inadequate or Imprecise Result or Readings
31
31
High Test Results
28
28
Incorrect Or Inadequate Test Results
27
27
Nonstandard Device
8
8
Leak/Splash
3
3
Appropriate Term/Code Not Available
3
3
False Device Output
1
1
Chemical Problem
1
1
Output Problem
1
1
Non Reproducible Results
1
1
False Reading From Device Non-Compliance
1
1
Use of Device Problem
1
1
Incorrect Measurement
1
1
Low Readings
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
438
438
No Clinical Signs, Symptoms or Conditions
182
182
No Consequences Or Impact To Patient
159
159
No Information
31
31
No Code Available
30
30
Test Result
5
5
Hepatitis
5
5
Exposure to Body Fluids
2
2
Emotional Changes
1
1
Misdiagnosis
1
1
Chemical Exposure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott GmbH
II
Apr-04-2024
2
ORTHO-CLINICAL DIAGNOSTICS
II
Sep-19-2014
3
OraSure Technologies, Inc.
III
Apr-18-2016
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