Recall Z-0071-2023— American Contract Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by American Contract Systems, Inc., initiated 2022-08-12. FDA's recall record names no specific 510(k) clearance for this event. Product: COVID Test Kit Nonsterile. Reason: Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device..
- Recalling firm
- American Contract Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-12
- Firm location
- Bloomington, MN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.