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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibrator, multi-analyte mixture
Product CodeJIX
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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 53 53
Low Test Results 19 19
Incorrect, Inadequate or Imprecise Result or Readings 6 6
High Readings 4 4
Incorrect Or Inadequate Test Results 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Non Reproducible Results 2 2
Defective Component 2 2
No Device Output 1 1
Device Sensing Problem 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 27 27
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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