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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 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 55 55
False Negative Result 33 33
Incorrect, Inadequate or Imprecise Result or Readings 33 33
Break 3 3
Fire 2 2
Defective Component 2 2
Component Missing 1 1
Defective Device 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Inaccurate Information 1 1
Missing Information 1 1
Leak/Splash 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 123 123
No Consequences Or Impact To Patient 9 9
Choking 2 2
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
No Code Available 1 1
Insufficient Information 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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