Summary
The FDA issued a Class II for S. Typhi/Para Typhi A Antigen by Changchun Wancheng Bio-Electron Co., Ltd.. Reason: 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. c.
Details
Source
Device Recall
External ID
Z-1261-2026
Action Date
2026-02-11
Status
Ongoing
Category
device
Product Description
S. Typhi/Para Typhi A Antigen
Lot/Code Info: Name/Lot(Expiration): S. Typhi/Para Typhi A Antigen/GT-STA 20251601(05-2027)
Quantity Affected: 1,000
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of TX, GA, CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-22
Company
Changchun, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 207 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Changchun Wancheng Bio-Electron Co., Ltd. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Changchun Wancheng Bio-Electron Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Changchun Wancheng Bio-Electron Co., Ltd. have FDA actions?
Changchun Wancheng Bio-Electron Co., Ltd. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1261-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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