Altruan GmbH recalls Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic strep…

Product not cleared by the FDA.

The firm distributed a Recall Notice via email to consignees who purchased affected devices from Altruan's website. The notice instructs consignees to immediately stop using recalled devices and to destroy/dispose of devices in consignee possession. Consignees are to reply to Altruan's email with their order number and confirmation of product disposal to receive a refund.

• FDA enforcement recordOfficial FDA database entry for Z-1559-2026
• FDA device classification · GTYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3740The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Altruan GmbHSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.