FDA-Device2026-02-11Class II
S. Typhi/Para Typhi A Antigen
Changchun Wancheng Bio-Electron Co., Ltd.
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.
Sold states
US Nationwide distribution in the states of TX, GA, CA.
Affected count
1,000
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Products
S. Typhi/Para Typhi A Antigen
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1261-2026Original summary
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
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