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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzymatic method, bilirubin
Product CodeJFM
Regulation Number 862.1110
Device Class 2

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

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Randox Laboratories Ltd. II Dec-06-2023
2 Siemens Healthcare Diagnostics, Inc. II Aug-28-2023
3 Siemens Healthcare Diagnostics, Inc. II Mar-20-2020
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