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TPLC
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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)
2016
2017
2018
2019
2020
2021
2022
2023
2024
19
16
17
11
13
8
0
0
0
MDR Year
MDR Reports
MDR Events
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
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
421
421
Adverse Event Without Identified Device or Use Problem
102
102
Low Test Results
84
84
False Positive Result
41
41
No Apparent Adverse Event
35
35
High Test Results
23
23
Incorrect Or Inadequate Test Results
20
20
Incorrect, Inadequate or Imprecise Result or Readings
16
16
Leak/Splash
2
2
Appropriate Term/Code Not Available
2
2
Non Reproducible Results
1
1
Output Problem
1
1
Incorrect Measurement
1
1
False Reading From Device Non-Compliance
1
1
Low Readings
1
1
Chemical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
394
394
No Clinical Signs, Symptoms or Conditions
154
154
No Consequences Or Impact To Patient
107
107
No Information
31
31
No Code Available
29
29
Hepatitis
5
5
Exposure to Body Fluids
2
2
Emotional Changes
1
1
Misdiagnosis
1
1
Test Result
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott GmbH
II
Apr-04-2024
2
OraSure Technologies, Inc.
III
Apr-18-2016
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