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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
Regulation Description Hematology quality control mixture.
Product CodeJPK
Regulation Number 864.8625
Device Class 2

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

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Adverse Event Without Identified Device or Use Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medline Industries Inc II Mar-12-2021
2 Primus Corporation dba Trinity Biotech III Dec-01-2022
3 R & D Systems, Inc. III Jan-19-2023
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