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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
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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