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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibrator, secondary
Regulation Description Calibrator.
Product CodeJIT
Regulation Number 862.1150
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 3
2022 4 4
2023 6 6
2024 17 17
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 29 29
Low Test Results 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
2 Ortho-Clinical Diagnostics II Jul-11-2023
3 Ortho-Clinical Diagnostics, Inc. II Jan-11-2024
4 Randox Laboratories Ltd. II Apr-17-2024
5 Siemens Healthcare Diagnostics, Inc. II Aug-24-2023
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