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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigens, all groups, streptococcus spp.
Product CodeGTY
Regulation Number 866.3740
Device Class 1


Premarket Reviews
ManufacturerDecision
HEALGEN SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 1 1
2021 37 37
2022 32 32
2023 44 44
2024 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 56 56
False Negative Result 47 47
Incorrect, Inadequate or Imprecise Result or Readings 37 37
Break 3 3
Fire 2 2
Defective Component 2 2
Leak/Splash 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Component Missing 1 1
Material Separation 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1
Missing Information 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 142 142
No Consequences Or Impact To Patient 9 9
Choking 2 2
No Code Available 1 1
No Information 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cypress Medical Products LLC II Sep-19-2024
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
3 Wondfo USA Co Ltd II Jun-07-2024
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