Strep A Test Recall: Altruan Clearest Cassette
Announced 2026-03-18 · FDA
Altruan GmbH recalled the Wondfo Streptococcal A At-Home Self-Test, an at-home test for group A beta-hemolytic streptococcal infection. The product was not cleared by the FDA and had US nationwide distribution. The recall number is Model No. 41972; No UDI; Lot Code: 6933289812337.
| Brand | Altruan GmbH |
|---|---|
| Product | Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection. |
| Reason | Product not cleared by the FDA. |
| Severity | moderate |
| Units affected | 188 |
| Distribution | US Nationwide distribution. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use the recalled test kit.
- If you have any of the recalled kits, contact Altruan GmbH for instructions on disposal or return (Model No. 41972, Lot 6933289812337).
- If you used the kit and have symptoms of strep throat, consult a healthcare professional.
How to identify the recalled item
| Lot / date codes | Model No. 41972; No UDI; Lot Code: 6933289812337. |
|---|---|
| Lot / date codes | Model No. SP-C310343-10; No UDI; Lot Code: 01242573. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other strep a test recalls
- Strep A Test Recall: Quidel 20108/20125/20108SC · 2026-05-20
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.