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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device covid-19 test home collection kit devices
Definition Specimens collected using the Home Collection Kit can be transported at ambient temperature for testing at a laboratory. SARS-CoV-2 RNA from the clinical specimen is maintained in the specimen packaging and suitable for use in diagnostic testing preformed using a molecular in vitro diagnostic (IVD) test for the detection of SARS-CoV-2 RNA that is authorized for use with the COVID-19 Test Home Collection Kit.
Product CodeQLW
Device Class Not Classified

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 6

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 2 2
Adverse Event Without Identified Device or Use Problem 1 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 7

Recalls
Manufacturer Recall Class Date Posted
1 Matrix Medical Network II Apr-15-2022
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