FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
- Recall number
- Z-2152-2025
- Recalling firm
- Beckman Coulter Inc.
- Product
- Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
- Status
- Open, Classified
- Initiated
- 2025-06-12
- Posted
- 2025-07-21
- Terminated
- not on file
- 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 different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 496 units
- Distribution
- US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands
- Lot, serial or model codes
- UDI: 15099590211615/Lot: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C
- 510(k) numbers
- ["K935013"]
- PMA numbers
- not on file
- Product code
- CGF
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28