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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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 52 53
Low Test Results 18 18
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 74 76
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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