Recall Z-2152-2025 ยท CGF Radioimmunoassay, Estrone
Beckman Coulter Inc.
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
| Date | Jul 21, 2025 (initiated Jun 12, 2025) |
| Status | Open, Classified |
| Reason | A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits. |
| Root cause | Nonconforming Material/Component |
| Action | On June 12, 2025, Beckman Coulter issued a "Urgent: Medical Device Recall" notification via Email. On July 8, 2025, Beckman Coulter issued a updated notification to provide additional information on the health risk and actions consignees should take. Beckman Coulter ask consignees to take the following actions: 1. Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. 2. Please discard any remaining inventory of effective lots per your laboratory protocols and ask for replacement. |
| Quantity | 496 units |
| Distribution | US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, 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 |