Changchun Wancheng Bio-Electron Co. recalled 1,000 units of S. Typhi/Para Typhi A Antigen test strips on November 22, 2025. The recall affects tests distributed nationwide, which may produce false results and lead to inappropriate medical intervention.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Changchun Wancheng Bio-Electron Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the S. Typhi/Para Typhi A Antigen test strips, model GT-STA 20251601, with an expiration date of May 2027. These were distributed across Texas, Georgia, and California. The tests were not legally marketed in the U.S. before distribution.
The test strips may yield false or inaccurate diagnostic results when used by laypersons. This could result in inappropriate medical interventions, posing significant health risks.
No specific incidents or injuries have been reported related to the use of these test strips. The potential for false results is the primary concern.
Patients and healthcare providers should stop using the test strips immediately. Follow recall instructions provided by the manufacturer. Contact Changchun Wancheng Bio-Electron Co. or your healthcare provider for guidance.
For more information, contact Changchun Wancheng Bio-Electron Co. at their official website or reach out to your healthcare provider.
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