FDA-Device2022-07-13Class I
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
American Contract Systems, Inc.
Hazard
Affected products were assembled off-site by individuals who may not have been properly trained.
Sold states
US distribution in the state of Minnesota.
Affected count
274,400 kits total
Manufactured in
2610 Ne Industrial Dr Ste 220, N/A, Kansas City, MO, United States
Products
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1277-2022Don't want to check this manually?
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