Reported Sep 25, 2024 · Ongoing

Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

Cypress Medical Products LLC

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: Cypress Medical Products LLC · 9954 Mayland Dr · Richmond, VA · 23233-1464

Is this the product you have?

  • Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Lot codes and dates
  • GTIN10815845020031; All Lots
Amount recalled
5 kits

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

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

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.