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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
Regulation Description Calibrator.
Product CodeJIX
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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