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TPLC
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Device
calibrator, multi-analyte mixture
Product Code
JIX
Regulation Number
862.1150
Device Class
2
MDR Year
MDR Reports
MDR Events
2017
17
17
2018
16
16
2019
12
12
2020
22
22
2021
9
9
2022
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
50
50
Low Test Results
18
18
Incorrect, Inadequate or Imprecise Resultor Readings
6
6
High Readings
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Incorrect Or Inadequate Test Results
3
3
Non Reproducible Results
2
2
Defective Component
2
2
Device Sensing Problem
1
1
No Device Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
46
46
No Clinical Signs, Symptoms or Conditions
23
23
No Consequences Or Impact To Patient
11
11
Laceration(s)
1
1
Test Result
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
AMS Diagnostics, LLC
III
Jul-13-2017
2
Beckman Coulter Inc
II
Jul-13-2017
3
Beckman Coulter Inc.
II
Feb-13-2018
4
Chromsystems Instruments & Chemicals GmbH
II
Dec-04-2020
5
Chromsystems Instruments & Chemicals GmbH
II
Dec-02-2020
6
ELITech Clinical Systems SAS
II
Aug-01-2018
7
Kamiya Biomedical Company, LLC
II
Oct-20-2017
8
Ortho Clinical Diagnostics
II
Aug-06-2019
9
Ortho Clinical Diagnostics Inc
II
Feb-13-2020
10
Ortho-Clinical Diagnostics
III
Sep-14-2018
11
Ortho-Clinical Diagnostics, Inc.
II
Mar-23-2021
12
Randox Laboratories Ltd.
II
May-12-2021
13
Randox Laboratories Ltd.
II
Nov-04-2019
14
Randox Laboratories Ltd.
III
Sep-07-2019
15
Randox Laboratories Ltd.
II
Dec-21-2018
16
Siemens Healthcare Diagnostics, Inc.
II
Feb-18-2020
17
Siemens Healthcare Diagnostics, Inc.
II
Mar-26-2018
18
Siemens Healthcare Diagnostics, Inc.
III
Feb-16-2017
19
Tosoh Bioscience Inc
III
Aug-15-2018
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