Z-2152-2025Class II

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

Name: Z-2152-2025 Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human...
Creator: Beckman Coulter Inc.
Published: 2025-06-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-06-12 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma on 2025-06-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2152-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-12
Posted: 2025-07-21
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Product code: CGF Radioimmunoassay, Estrone
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 496 units
Distribution: US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands
Product codes and lots: UDI: 15099590211615/Lot: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2152-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2152-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21

Product code CGF

K935013Class IDsl Estrone (Dsl 8700)Diagnostic Systems Laboratories, Inc. / cleared 1994-06-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)