Z-2336-2025Class II

Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual...

Name: Z-2336-2025 Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual...
Creator: Immunotech A.S.
Published: 2025-06-12
License: https://open.fda.gov/license/

IMMUNOTECH s.r.o. / initiated 2025-06-12 / Open, Classified / root cause: manufacturing process

FDA source

Immunotech A.S. began a recall of Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for... on 2025-06-12. FDA classified it as Class II and gives the reason as "Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote...". 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-2336-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-12
Posted: 2025-08-18
Recalling firm: IMMUNOTECH s.r.o.
Product: Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
Product code: CGF Radioimmunoassay, Estrone
Reason for recall: Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 06/12/2025, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Beckman Coulter determined that the Estrone RIA kit might be affected by an isolated coated tubes inhomogeneity issue causing falsely elevated results or falsely decreased results. Customers are instructed to: Beckman Coulter recommends sharing the content of the Recall Letter with their laboratory and/or medical director regarding the need to review previous patient test results. Note- All affected product have expired (expiry dates 12/31/2024 thru 04/22/2025) For questions, contact Customer Support Center: Website: http://www.beckmancoulter.com Email: [email protected]
Quantity in commerce: 279 units
Distribution: Worldwide - U.S. Nationwide distribution in the states of NC and the countries of Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and Netherlands.
Product codes and lots: Catalog Number DSL8700 UDI Code: 15099590211615 Serial/Lot Numbers: 241014D 241111C 241209C 241209D 250106C 250106D 250203C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2336-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2336-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-18

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)