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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, porphyrin, spectrophotometry, lithium
Product CodeNDW
Regulation Number 862.3560
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 1 1
High Test Results 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sentinel CH SpA II Sep-20-2019
2 Siemens Healthcare Diagnostics, Inc. II Oct-20-2022
3 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
4 Siemens Healthcare Diagnostics, Inc. II Jun-26-2020
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