Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and pl
Summary
The FDA issued a Class II for Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative meas by Beckman Coulter Inc.. 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 differen.
Details
Source
Device Recall
External ID
Z-2152-2025
Action Date
2025-07-30
Status
Ongoing
Category
device
Product Description
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Lot/Code Info: UDI: 15099590211615/Lot: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C
Quantity Affected: 496 units
Reason for Recall
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.
Distribution
US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-12
Company
Brea, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Inc. have FDA actions?
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2152-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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