Recall Z-2336-2025 ยท CGF Radioimmunoassay, Estrone
Immunotech A.S.
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
| Date | Aug 18, 2025 (initiated Jun 12, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 Custom |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935013 | DSL ESTRONE (DSL 8700) Diagnostic Systems Laboratories, Inc., Jun 16, 1994 |