Z-0071-2023 Class II Ongoing
FDA device recall Z-0071-2023 was initiated by American Contract Systems, Inc. on Aug 12, 2022 and is designated Class II. Reason for recall: Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device. The recall status is ongoing. Affected quantity: 39,575 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 19, 2022
- Initiation Date
- Aug 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39,575 kits
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.
Distribution Pattern
Distribution to one customer in PA only
Code Information
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0071-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026