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Recall Observatory FDA recall evidence

Device product

COVID Test Kit Nonsterile

Z-0071-2023

August 12, 2022

Class II

Product summary

Firm
American Contract Systems, Inc.
Event
Event 90800
Status
Ongoing
Classification
Class II
Quantity
39,575 kits
Official record key
device-enforcement:Z-0071-2023

Official wording

Reason: Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.

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)

Distribution pattern: Distribution to one customer in PA only

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled