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TPLC
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Device
calibrator, multi-analyte mixture
Regulation Description
Calibrator.
Product Code
JIX
Regulation Number
862.1150
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
22
22
2021
9
9
2022
11
11
2023
13
13
2024
17
17
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
49
49
Low Test Results
15
15
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Defective Component
2
2
Non Reproducible Results
1
1
Device Sensing Problem
1
1
Material Split, Cut or Torn
1
1
High Readings
1
1
Insufficient Information
1
1
No Device Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
56
56
No Known Impact Or Consequence To Patient
12
12
No Consequences Or Impact To Patient
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Chromsystems Instruments & Chemicals GmbH
II
Dec-04-2020
2
Chromsystems Instruments & Chemicals GmbH
II
Dec-02-2020
3
Ortho Clinical Diagnostics Inc
II
Feb-13-2020
4
Ortho-Clinical Diagnostics, Inc.
II
Mar-23-2021
5
Randox Laboratories Ltd.
II
May-03-2024
6
Randox Laboratories Ltd.
II
Mar-20-2024
7
Randox Laboratories Ltd.
II
Jan-18-2024
8
Randox Laboratories Ltd.
II
Jan-18-2024
9
Randox Laboratories Ltd.
II
Jan-18-2024
10
Randox Laboratories Ltd.
II
Aug-23-2023
11
Randox Laboratories Ltd.
II
May-12-2021
12
Siemens Healthcare Diagnostics Inc
II
Dec-21-2023
13
Siemens Healthcare Diagnostics, Inc.
II
Feb-18-2020
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