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TPLC
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show TPLC since
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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
2018
16
16
2019
12
12
2020
22
22
2021
9
9
2022
11
11
2023
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
53
53
Low Test Results
15
15
Incorrect, Inadequate or Imprecise Result or Readings
6
6
Adverse Event Without Identified Device or Use Problem
3
3
High Readings
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 Clinical Signs, Symptoms or Conditions
39
39
No Known Impact Or Consequence To Patient
35
35
No Consequences Or Impact To Patient
6
6
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Feb-13-2018
2
Chromsystems Instruments & Chemicals GmbH
II
Dec-04-2020
3
Chromsystems Instruments & Chemicals GmbH
II
Dec-02-2020
4
ELITech Clinical Systems SAS
II
Aug-01-2018
5
Ortho Clinical Diagnostics
II
Aug-06-2019
6
Ortho Clinical Diagnostics Inc
II
Feb-13-2020
7
Ortho-Clinical Diagnostics
III
Sep-14-2018
8
Ortho-Clinical Diagnostics, Inc.
II
Mar-23-2021
9
Randox Laboratories Ltd.
II
Aug-23-2023
10
Randox Laboratories Ltd.
II
May-12-2021
11
Randox Laboratories Ltd.
II
Nov-04-2019
12
Randox Laboratories Ltd.
III
Sep-07-2019
13
Randox Laboratories Ltd.
II
Dec-21-2018
14
Siemens Healthcare Diagnostics, Inc.
II
Feb-18-2020
15
Siemens Healthcare Diagnostics, Inc.
II
Mar-26-2018
16
Tosoh Bioscience Inc
III
Aug-15-2018
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