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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device multiple use blood lancet for single patient use only
Regulation Description Blood lancets.
Definition A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Product CodeQRL
Regulation Number 878.4850
Device Class 2


Premarket Reviews
ManufacturerDecision
ARKRAY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASAHI POLYSLIDER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASCENSIA DIABETES CARE U.S., INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIONIME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FACET TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 3
GOSTAR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIFUN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OWEN MUMFORD, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERILANCE MEDICAL (SUZHOU), INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
TIANJIN RILIFINE MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRIVIDIA HEALTH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 2
2023 3 3
2024 7 7
2025 134 134
2026 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Retraction Problem 196 196
Product Quality Problem 5 6
Component Missing 4 4
Insufficient Device Problem Information 2 2
Material Integrity Problem 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Dull, Blunt 1 1
Contamination 1 1
Material Separation 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Improper or Incorrect Procedure or Method 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 199 199
Needle Stick/Puncture 5 5
Skin Inflammation/ Irritation 3 3
Pain 3 3
Hyperglycemia 2 2
Erythema 2 2
Shaking/Tremors 2 2
Presyncope 1 1
Low Blood Pressure/ Hypotension 1 2
Skin Discoloration 1 1
Neuropathy 1 1
Fatigue 1 1
Swelling/ Edema 1 1
Muscle Weakness/Atrophy 1 2
Headache 1 1
Urinary Frequency / Polyuria 1 1
Insufficient Information 1 1
Bruise/Contusion 1 1
Dizziness 1 2
Fever 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Home Health US, Incorporated III Oct-21-2025
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