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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
2019 215 215
2020 12 12
2021 3 3
2022 4 4
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 225 225
Low Test Results 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Failure to Calibrate 1 1
High Readings 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 200 200
No Clinical Signs, Symptoms or Conditions 19 19
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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