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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, c-peptides of proinsulin
Product CodeJKD
Regulation Number 862.1135
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 3 3
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
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 Jun-26-2015
3 DRG International, Inc. II Apr-07-2022
4 Tosoh Bioscience Inc II Jun-05-2018
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