FDAHealthJune 12, 2025
Beckman Coulter Inc. — Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
⚠️ 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.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- June 12, 2025
US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands
What's affected?
- Product
- Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
- Brand
- Beckman Coulter Inc.
- Lot code
- 250106D
Additional details
UDI: 15099590211615/Lot: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 496 units.
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