Estrone RIA (Beckman Coulter) – BSA Lot Variation (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Codes / Batch Numbers
UDI: 15099590211615/Lot: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C
Products Sold
UDI: 15099590211615/Lot: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C
Beckman Coulter Inc. is recalling Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in due to 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 differen. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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. 2. Please share this information with your laboratory staff and retain this notifications as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. 3. Please respond within 10 days in one of the following ways: 1. Electronically, if you received the notification via email, 2. Manually, complete and return the enclosed Response Form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NC
Page updated: Jan 10, 2026