Reported Jul 30, 2025 · Ongoing
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- Estrone RIA
- REFDSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma
- Lot codes and dates
- UDI
15099590211615/Lot: 250106D250203C250203D250303C250331C250428C250526C
- UDI
- Amount recalled
- 496 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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