Recall Weekly
Moderate riskFDA DeviceClass II

Changchun Wancheng S. Typhi/Para Typhi A Antigen test strips recalled for inaccurate results

Changchun Wancheng Bio-Electron distributed S. Typhi/Para Typhi A Antigen test strips in the U.S. before receiving required FDA approval. These test strips may produce false or inaccurate results when used by patients or untrained individuals, which could lead to wrong medical decisions.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using lot GT-STA 20251601 (expires 05-2027)
  2. Do not rely on results from these test strips for medical decisions
  3. Discard the test strips safely
  4. Contact your healthcare provider if you used these strips and received a diagnosis
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
S. Typhi/Para Typhi A Antigen
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 11 products — see all of them.

Details

Units affected
1,000
Illnesses reported
None reported
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Classification
Class II
Recall number
Z-1261-2026

In the FDA's words

Description
S. Typhi/Para Typhi A Antigen Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Name/Lot(Expiration): S. Typhi/Para Typhi A Antigen/GT-STA 20251601(05-2027) Distribution: US Nationwide distribution in the states of TX, GA, CA. Affected quantity: 1,000
Hazard
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

11 products in this recall

LotFancy, Vivoo and URIMED urine test strips recalled over unauthorized marketing

Changchun Wancheng is recalling 11 product listings of home test strips and diagnostic tests, including urinary tract infection, ovulation, menopause, fertility and Vivoo tests. The devices were distributed in the U.S. before FDA clearance (510(k)), and they may give false or inaccurate results to users, which could lead to inappropriate medical treatment. The recall was distributed nationwide, with confirmed distribution in Texas, Georgia and California.

The agency lists each product separately. Check every one you might have.

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