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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 15 15
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 56 56
Low Test Results 14 14
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Defective Component 2 2
Material Split, Cut or Torn 1 1
Non Reproducible Results 1 1
High Readings 1 1
Device Sensing Problem 1 1
False Positive Result 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 63 63
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 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
4 Ortho Clinical Diagnostics Inc II Feb-13-2020
5 Ortho-Clinical Diagnostics, Inc. II Mar-23-2021
6 Randox Laboratories Ltd. II May-03-2024
7 Randox Laboratories Ltd. II Mar-20-2024
8 Randox Laboratories Ltd. II Jan-18-2024
9 Randox Laboratories Ltd. II Jan-18-2024
10 Randox Laboratories Ltd. II Jan-18-2024
11 Randox Laboratories Ltd. II Aug-23-2023
12 Randox Laboratories Ltd. II May-12-2021
13 Siemens Healthcare Diagnostics Inc II Dec-21-2023
14 Siemens Healthcare Diagnostics, Inc. II Feb-18-2020
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