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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
2020 12 12
2021 3 3
2022 4 4
2023 6 6
2024 17 17
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 34 34
Low Test Results 21 21
Incorrect, Inadequate or Imprecise Result or Readings 3 3
High Readings 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
No Known Impact Or Consequence To Patient 4 4
No Patient Involvement 3 3
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III May-05-2020
2 Abbott Laboratories II Apr-09-2020
3 Ortho-Clinical Diagnostics II Jul-11-2023
4 Ortho-Clinical Diagnostics, Inc. II Jan-11-2024
5 Randox Laboratories Ltd. II Apr-17-2024
6 Siemens Healthcare Diagnostics, Inc. II Aug-24-2023
7 Siemens Healthcare Diagnostics, Inc. II Oct-13-2020
8 Tosoh Bioscience Inc II Sep-14-2020
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