Recall Z-1560-2026
Altruan GmbH · initiated December 19, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Codes / lots: Model No. SP-C310343-10; No UDI; Lot Code: 01242573.
Reason for recall
Product not cleared by the FDA.
FDA-determined cause: No Marketing Application
Action taken
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.
Details
- Recall number
- Z-1560-2026
- Initiated
- December 19, 2025
- Posted by FDA
- March 12, 2026
- Product code
- GTY – Antigens, All Groups, Streptococcus Spp.
- Quantity
- 188 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Altruan GmbH, Massing
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1559-2026 Class II | Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic…Product not cleared by the FDA. | 12/19/2025Open, Classified |
| Z-1561-2026 Class II | Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal…Product not cleared by the FDA. | 12/19/2025Open, Classified |