FDA-Device2022-10-19Class II
COVID Test Kit Nonsterile
American Contract Systems, Inc.
Hazard
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
Sold states
Distribution to one customer in PA only
Affected count
39,575 kits
Manufactured in
4801 W 81st St, N/A, Bloomington, MN, United States
Products
COVID Test Kit Nonsterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2023Don't want to check this manually?
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