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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device calibrators, drug specific
Product CodeDLJ
Regulation Number 862.3200
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2022 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 3 3
Low Test Results 2 2

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 Ortho-Clinical Diagnostics, Inc. II May-30-2023
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