FDA Device recall Z-1369-2026
Estrone RIA, REF: DSL8700
- FDA Device
- Class II
- ongoing
- Published 2026-02-25
On 2026-02-25 the FDA classified a Class II recall of Estrone RIA, REF: DSL8700 by Immunotech A S, citing the affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the iss….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1369-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-15 |
| Published | 2026-02-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Immunotech A S |
| Distribution | US |
Product
Estrone RIA, REF: DSL8700
Reason
The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.
Identifiers
| code_info | UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27) |
|---|
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-1369-2026%22
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