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 S. Typhi/Para Typhi A Antigen test strips are used for diagnosing infections caused by the bacteria S. Typhi and Para Typhi. Consumers may use these strips for quick testing, particularly in near-patient settings.
The test strips can produce false or inaccurate results, especially if used by individuals without medical training. Such inaccuracies can lead to incorrect diagnoses and treatment decisions.
This recall is not part of a broader industry pattern.
Consumers may face health risks due to potential misdiagnosis from false results. This could lead to unnecessary treatments or delays in appropriate care.
The model number and expiration date can typically be found on the product box or label.
Expect a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
Keep copies of receipts, correspondence with the manufacturer, and any documentation related to the recall for your records.
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.
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