CLASS II ONGOING Device recall · Reported 19 Oct 2022 · FDA Enforcement Report

Covid Test Kit Nonsterile recalled by American Contract Systems

American Contract Systems is recalling Covid Test Kit Nonsterile, distributed in Pennsylvania. The recall was initiated on 12 Aug 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 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)

Quantity recalled39,575 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0071-2023
FDA event ID: 90800
Recalling firm: American Contract Systems, Bloomington, MN
Classification: Class II
Status: Ongoing
Recall initiated: 12 Aug 2022
FDA classified: 8 Oct 2022
Reported: 19 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Test Kits & Diagnostics

Timeline

12 Aug 2022	Recall initiated by company
8 Oct 2022	Classified by FDA	+57 days
19 Oct 2022	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

COVID Test Kit Nonsterile

Where it was distributed

Distribution to one customer in PA only

Pennsylvania

Questions about this recall

Is Covid Test Kit Nonsterile recalled?

Yes. American Contract Systems recalled Covid Test Kit Nonsterile on 12 Aug 2022. The recall is Class II and its status is Ongoing. Recall number Z-0071-2023.

Why was it recalled?

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

Which lots are affected?

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)

Where was it sold?

Distribution to one customer in PA only

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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