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TPLC
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show TPLC since
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Device
hepatitis a test (antibody and igm antibody)
Product Code
LOL
Regulation Number
866.3310
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
2
BIO-RAD LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
2
DIASORIN INC.
SUBSTANTIALLY EQUIVALENT
4
DIASORIN, INC.
SUBSTANTIALLY EQUIVALENT
2
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
ROCHE PROFESSIONAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
19
19
2015
28
28
2016
36
36
2017
26
26
2018
61
61
2019
51
51
2020
104
104
2021
12
12
2022
17
17
2023
36
36
2024
16
16
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
178
178
High Test Results
154
154
False Negative Result
20
20
Incorrect Or Inadequate Test Results
20
20
Adverse Event Without Identified Device or Use Problem
15
15
Incorrect, Inadequate or Imprecise Result or Readings
12
12
Non Reproducible Results
6
6
Low Test Results
6
6
False Reading From Device Non-Compliance
2
2
Output Problem
1
1
Insufficient Information
1
1
Patient Data Problem
1
1
Optical Problem
1
1
Computer Software Problem
1
1
High Readings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
215
215
No Clinical Signs, Symptoms or Conditions
80
80
No Patient Involvement
54
54
No Consequences Or Impact To Patient
54
54
Hepatitis
2
2
Reaction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Diagnostics International, Ltd.
II
May-19-2010
2
Abbott Gmbh & Co. KG
II
Apr-17-2020
3
Abbott Gmbh & Co. KG
II
Nov-26-2019
4
Abbott Laboratories
II
Jun-06-2011
5
Roche Diagnostics Corporation
II
Jan-29-2019
6
Roche Diagnostics Operations, Inc.
II
Dec-12-2019
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