FDA recall Z-0071-2023
American Contract Systems, Inc. · Class II · device
Product
COVID Test Kit Nonsterile
Reason for recall
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
Distribution
Distribution to one customer in PA only
Key facts
- Status
- Ongoing
- Initiation date
- 2022-08-12
- Report date
- 2022-10-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Bloomington, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2023