Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and pla

FDA device recall Z-2152-2025 · posted 2025-07-21 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

CGF

Quantity affected

496 units

Distribution

US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands

Date initiated

2025-06-12

Date posted

2025-07-21

Location

Brea, CA

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