FDA Device recall Z-1560-2026
Clearest Strep-A Cassette Test
- FDA Device
- Class II
- ongoing
- Published 2026-03-18
On 2026-03-18 the FDA classified a Class II recall of Clearest Strep-A Cassette Test by Altruan, citing product not cleared by the FDA.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1560-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-19 |
| Published | 2026-03-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Altruan |
| Distribution | US |
Product
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Reason
Product not cleared by the FDA.
Identifiers
| code_info | Model No. SP-C310343-10; No UDI; Lot Code: 01242573. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1560-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.