Changchun Wancheng S. Typhi/Para Typhi A Antigen test strips recalled for inaccurate results
What this means
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.
- Stop using lot GT-STA 20251601 (expires 05-2027)
- Do not rely on results from these test strips for medical decisions
- Discard the test strips safely
- Contact your healthcare provider if you used these strips and received a diagnosis
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1261-2026Want us to check the next one for you?
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