Reported Oct 19, 2022 · Ongoing

COVID Test Kit Nonsterile

American Contract Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: American Contract Systems, Inc. · 4801 W 81st St · Bloomington, MN · 55437-1111

Is this the product you have?

  • COVID Test Kit Nonsterile
Lot codes and dates
  • 1)
  • UDI-DIProduct
  • CodeAHCV18A, Lots 980221 (exp. 01/20/2023) and 974221 (exp. 01/25/2023) 2)
  • UDI-DIProduct
  • Code
    • AHCV18B
    • Lots 868221 (exp. 05/31/2023)
    • 842221 (exp. 05/31/2023)
Amount recalled
39,575 kits

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

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