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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
2018 8 8
2019 215 215
2020 12 12
2021 4 4
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 225 225
Low Test Results 11 11
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Adverse Event Without Identified Device or Use Problem 2 2
Non Reproducible Results 1 1
High Readings 1 1
Failure to Calibrate 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 200 200
No Known Impact Or Consequence To Patient 22 22
No Clinical Signs, Symptoms or Conditions 12 12
No Consequences Or Impact To Patient 5 5
Exposure to Body Fluids 2 2
Eye Injury 2 2
No Code Available 2 2

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 Medica Corporation II Mar-28-2018
6 Randox Laboratories Ltd. II Mar-15-2019
7 Siemens Healthcare Diagnostics, Inc. II Oct-13-2020
8 Siemens Healthcare Diagnostics, Inc. II Jan-29-2019
9 Tosoh Bioscience Inc II Sep-14-2020
10 Tosoh Bioscience Inc II May-14-2018
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