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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
2018 12 12
2019 6 6
2020 1 1
2021 37 37
2022 32 32
2023 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 48 48
False Negative Result 39 39
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Break 3 3
Fire 2 2
Defective Component 2 2
Component Missing 1 1
Defective Device 1 1
Chemical Spillage 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
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 100 100
No Consequences Or Impact To Patient 19 19
Choking 2 2
No Information 2 2
No Code Available 2 2
No Known Impact Or Consequence To Patient 1 1
Bacterial Infection 1 1
Red Eye(s) 1 1

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