Recall archive / FDA device enforcement
COVID Test Kit Nonsterile — FDA record Z-0071-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 12, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 39,575 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0071-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution to one customer in PA only
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 19, 2022
- Recall initiation date
- Aug 12, 2022
- Center classification date
- Oct 8, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.