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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
2019 12 12
2020 22 22
2021 9 9
2022 11 11
2023 13 13
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 49 49
Low Test Results 14 14
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Defective Component 2 2
Non Reproducible Results 2 2
High Readings 2 2
Device Sensing Problem 1 1
Material Split, Cut or Torn 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 3 3
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 II Aug-06-2019
4 Ortho Clinical Diagnostics Inc II Feb-13-2020
5 Ortho-Clinical Diagnostics, Inc. II Mar-23-2021
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 Randox Laboratories Ltd. II Nov-04-2019
13 Randox Laboratories Ltd. III Sep-07-2019
14 Siemens Healthcare Diagnostics Inc II Dec-21-2023
15 Siemens Healthcare Diagnostics, Inc. II Feb-18-2020
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