Changchun Wancheng Bio-Electron recalls unapproved S. Typhi/Para Typhi A Antigen test strips that may give false results, leading to incorrect medical treatment. Affected units sold before legal U.S. marketing.
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.
Changchun Wancheng Bio-Electron is recalling unapproved S. Typhi/Para Typhi A Antigen test strips that could give false results. This might lead to incorrect medical treatment if used by laypeople.
The test strips were distributed before they could be legally marketed in the U.S. This means they might not work correctly, causing false results. If a person uses them, they could get the wrong medical advice and treatment.
People who bought or use these unapproved test strips for near-patient testing. Those with limited medical knowledge are most at risk of incorrect treatment.
Check for the product name 'S. Typhi/Para Typhi A Antigen' and lot number GT-STA 20251601(05-2027). These strips were sold before U.S. approval.
Look for the lot number GT-STA 20251601(05-2027) on the test strips.
The recall states these strips may cause false results, so they are not safe for accurate diagnosis.
The recall does not specify a remedy, so check with the manufacturer for guidance.
They were distributed before legal U.S. marketing, which may cause false results and incorrect medical treatment.
We’ve drafted a message you can send Changchun Wancheng Bio-Electron to request your refund or repair — edit it as you like.
Subject: Recall Z-1261-2026 — Changchun Wancheng Bio-Electron Changchun Wancheng Bio-Electron Hello, I own a Changchun Wancheng Bio-Electron that is covered by recall Z-1261-2026 from Changchun Wancheng Bio-Electron. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
