FDA Device recall Z-0071-2023
COVID Test Kit Nonsterile
- FDA Device
- Class II
- ongoing
- Published 2022-10-19
On 2022-10-19 the FDA classified a Class II recall of COVID Test Kit Nonsterile by American Contract Systems, citing kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0071-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-12 |
| Published | 2022-10-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | American Contract Systems |
| Distribution | PA |
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.
Identifiers
| code_info | 1) UDI-DI: Product Code: AHCV18A, Lots 980221 (exp. 01/20/2023) and 974221 (exp. 01/25/2023) 2) UDI-DI: Product Code:…1) UDI-DI: Product Code: AHCV18A, Lots 980221 (exp. 01/20/2023) and 974221 (exp. 01/25/2023) 2) UDI-DI: Product Code: AHCV18B, Lots 868221 (exp. 05/31/2023), 842221 (exp. 05/31/2023) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0071-2023%22
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