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TPLC
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show TPLC since
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Device
calibrator, secondary
Product Code
JIT
Regulation Number
862.1150
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
8
8
2019
215
215
2020
12
12
2021
4
4
2022
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
225
225
Low Test Results
11
11
Incorrect, Inadequate or Imprecise Result or Readings
9
9
Adverse Event Without Identified Device or Use Problem
2
2
Non Reproducible Results
1
1
High Readings
1
1
Failure to Calibrate
1
1
Calibration Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
200
200
No Known Impact Or Consequence To Patient
22
22
No Clinical Signs, Symptoms or Conditions
12
12
No Consequences Or Impact To Patient
5
5
Exposure to Body Fluids
2
2
Eye Injury
2
2
No Code Available
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
III
May-05-2020
2
Abbott Laboratories
II
Apr-09-2020
3
Abbott Laboratories
III
Jul-25-2019
4
Abbott Laboratories
III
May-16-2019
5
Medica Corporation
II
Mar-28-2018
6
Randox Laboratories Ltd.
II
Mar-15-2019
7
Siemens Healthcare Diagnostics, Inc.
II
Oct-13-2020
8
Siemens Healthcare Diagnostics, Inc.
II
Jan-29-2019
9
Tosoh Bioscience Inc
II
Sep-14-2020
10
Tosoh Bioscience Inc
II
May-14-2018
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