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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device turbidimetric, total protein
Product CodeJGQ
Regulation Number 862.1635
Device Class 2


Premarket Reviews
ManufacturerDecision
HITACHI CHEMICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 3 3
2017 2 2
2018 3 3
2019 5 5
2020 2 2
2021 2 2
2022 1 1
2023 7 7
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 14 14
Low Test Results 10 10
Non Reproducible Results 6 6
Incorrect, Inadequate or Imprecise Result or Readings 2 2
False Positive Result 1 1
Material Integrity Problem 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 7 7
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Oct-17-2013
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