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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
2021 9 9
2022 11 13
2023 13 13
2024 15 15
2025 18 18
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 51 52
Low Test Results 13 13
Incorrect, Inadequate or Imprecise Result or Readings 4 6
Chemical Problem 1 1
Material Split, Cut or Torn 1 1
Unable to Obtain Readings 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 68 70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
2 Ortho-Clinical Diagnostics, Inc. II Mar-23-2021
3 Randox Laboratories Ltd. II May-03-2024
4 Randox Laboratories Ltd. II Mar-20-2024
5 Randox Laboratories Ltd. II Jan-18-2024
6 Randox Laboratories Ltd. II Jan-18-2024
7 Randox Laboratories Ltd. II Jan-18-2024
8 Randox Laboratories Ltd. II Aug-23-2023
9 Randox Laboratories Ltd. II May-12-2021
10 Siemens Healthcare Diagnostics Inc II Dec-21-2023
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