Class 2 Device Recall Clearest

• Date Initiated by Firm: December 19, 2025
• Date Posted: March 12, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1560-2026
• Recall Event ID: 98472
• Product Classification: Antigens, all groups, streptococcus spp. - Product Code GTY
• Product: Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
• Code Information: Model No. SP-C310343-10; No UDI; Lot Code: 01242573.
• FEI Number: 3042770115
• Recalling Firm/ Manufacturer: Altruan GmbH; Morolding 6; Massing Germany
• For Additional Information Contact: Customer Service; 87242859602
• Manufacturer Reason for Recall: Product not cleared by the FDA.
• FDA Determined Cause: No Marketing Application
• Action: 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.
• Quantity in Commerce: 188 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.