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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device acid, uric, uricase (colorimetric)
Product CodeKNK
Regulation Number 862.1775
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 2 2
Non Reproducible Results 2 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Mar-02-2020
2 Beckman Coulter Inc. II Oct-24-2019
3 Beckman Coulter Inc. II May-12-2017
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