Estrone RIA, REF: DSL8700
FDA device recall Z-1369-2026 · posted 2026-02-13 · Open, Classified
Recall details
- Recalling firm
- Immunotech A.S.
- Reason for recall
- 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.
- Action taken
- On 12/15/2025, Beckman Coulter emailed recall notices to customers who were informed of the following: 1) Discard any remaining inventory of affected lots per your laboratory protocols and ask for replacement. 2) Firm recommends sharing the content of this letter with your laboratory and/or medical director. 3) If you have forwarded any of the affected products to another laboratory, provide them a copy of this letter. 4) Complete and return the response form via email to QACZ@beckman.com Questions can be sent to the firm via email at imunochem@beckman.com
- Root cause
- Equipment maintenance
- Status
- Open, Classified
- Product code
- CGF
- Quantity affected
- 160
- Distribution
- Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
- Date initiated
- 2025-12-15
- Date posted
- 2026-02-13
- Location
- Prague 10, Czech Republic
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DSL ESTRONE (DSL 8700) (K935013) | Diagnostic Systems Laboratories, Inc. | 1994-06-16 |