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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mixture, hematology quality control
Product CodeJPK
Regulation Number 864.8625
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Adverse Event Without Identified Device or Use Problem 1 1
Coagulation in Device or Device Ingredient 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Consequences Or Impact To Patient 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton, Dickinson and Company, BD Biosciences II Dec-10-2020
2 Medline Industries Inc II Mar-12-2021
3 Primus Corporation dba Trinity Biotech III Dec-01-2022
4 R & D Systems, Inc. III Jan-19-2023
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