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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibrator, secondary
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

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 33 33
Low Test Results 18 18
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 34 34
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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