Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device
FDA device recall Z-2336-2025 · posted 2025-08-18 · Open, Classified
Recall details
- Recalling firm
- Immunotech A.S.
- Reason for recall
- Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.
- Action taken
- On 06/12/2025, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Beckman Coulter determined that the Estrone RIA kit might be affected by an isolated coated tubes inhomogeneity issue causing falsely elevated results or falsely decreased results. Customers are instructed to: Beckman Coulter recommends sharing the content of the Recall Letter with their laboratory and/or medical director regarding the need to review previous patient test results. Note- All affected product have expired (expiry dates 12/31/2024 thru 04/22/2025) For questions, contact Customer Support Center: Website: http://www.beckmancoulter.com Email: imunochem@beckman.com
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- CGF
- Quantity affected
- 279 units
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of NC and the countries of Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and Netherlands.
- Date initiated
- 2025-06-12
- Date posted
- 2025-08-18
- Location
- Prague 10, Czech Republic
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DSL ESTRONE (DSL 8700) (K935013) | Diagnostic Systems Laboratories, Inc. | 1994-06-16 |