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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nephelometer
Product CodeJZW
Regulation Number 866.4540
Device Class 1

MDR Year MDR Reports MDR Events
2016 3 3
2017 2 2
2018 8 8
2020 6 6
2021 6 6
2022 5 5
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
High Test Results 4 4
Incorrect Or Inadequate Test Results 2 2
Mechanical Problem 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 15 15

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Aug-22-2019
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