Z-1261-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2026
- Initiation Date
- November 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,000
Product Description
S. Typhi/Para Typhi A Antigen
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 Pattern
US Nationwide distribution in the states of TX, GA, CA.
Code Information
Name/Lot(Expiration): S. Typhi/Para Typhi A Antigen/GT-STA 20251601(05-2027)