FDA recall Z-1277-2022

American Contract Systems, Inc. · Class I · device

Product

Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

Reason for recall

Affected products were assembled off-site by individuals who may not have been properly trained.

Distribution

US distribution in the state of Minnesota.

Key facts

Status
Ongoing
Initiation date
2022-05-02
Report date
2022-07-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kansas City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1277-2022