Reported Jun 19, 2024 · Ongoing

Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo…

Wondfo USA Co. Ltd.

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: Wondfo USA Co Ltd · 545 Willowbrook Center Pkwy Ste B · Willowbrook, IL · 60527-8436

Is this the product you have?

  • Streptococcal A rapid test kits
  • labeled asWondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test Strip, SMC Direct, LLC, RefuAH Strep A Rapid
Lot codes and dates
  • part numbers and lot numbers are unknown
Amount recalled
N/A

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.

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, 7:36 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.