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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, urine leukocyte
Product CodeLJX
Regulation Number 864.7675
Device Class 1


Premarket Reviews
ManufacturerDecision
HEALGEN SCIENTIFIC LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2016 1 1
2017 1 1
2021 2 2
2022 1 1
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 5 5
High Readings 2 2
Device Operates Differently Than Expected 1 1
Data Problem 1 1
Patient Data Problem 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Urinary Tract Infection 3 3
No Information 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARKRAY USA INC. III Sep-30-2010
2 Beckman Coulter Inc. II May-18-2018
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