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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
2019 215 215
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 240 240
Low Test Results 24 24
Incorrect, Inadequate or Imprecise Result or Readings 9 9
High Readings 1 1
Calibration Problem 1 1
Failure to Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 200 200
No Clinical Signs, Symptoms or Conditions 38 38
No Known Impact Or Consequence To Patient 18 18
No Consequences Or Impact To Patient 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III May-05-2020
2 Abbott Laboratories II Apr-09-2020
3 Abbott Laboratories III Jul-25-2019
4 Abbott Laboratories III May-16-2019
5 Ortho-Clinical Diagnostics II Jul-11-2023
6 Ortho-Clinical Diagnostics, Inc. II Jan-11-2024
7 Randox Laboratories Ltd. II Apr-17-2024
8 Randox Laboratories Ltd. II Mar-15-2019
9 Siemens Healthcare Diagnostics, Inc. II Aug-24-2023
10 Siemens Healthcare Diagnostics, Inc. II Oct-13-2020
11 Siemens Healthcare Diagnostics, Inc. II Jan-29-2019
12 Tosoh Bioscience Inc II Sep-14-2020
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