Z-1369-2026Class II

Estrone RIA, REF: DSL8700

Name: Z-1369-2026 Estrone RIA, REF: DSL8700
Creator: Immunotech A.S.
Published: 2025-12-15
License: https://open.fda.gov/license/

IMMUNOTECH s.r.o. / initiated 2025-12-15 / Open, Classified / root cause: manufacturing process

FDA source

Immunotech A.S. began a recall of Estrone RIA, REF: DSL8700 on 2025-12-15. FDA classified it as Class II and gives the reason as "The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur". 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-1369-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-15
Posted: 2026-02-13
Recalling firm: IMMUNOTECH s.r.o.
Product: Estrone RIA, REF: DSL8700
Product code: CGF Radioimmunoassay, Estrone
Reason for recall: The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On 12/15/2025, Beckman Coulter emailed recall notices to customers who were informed of the following: 1) Discard any remaining inventory of affected lots per your laboratory protocols and ask for replacement. 2) Firm recommends sharing the content of this letter with your laboratory and/or medical director. 3) If you have forwarded any of the affected products to another laboratory, provide them a copy of this letter. 4) Complete and return the response form via email to [email protected] Questions can be sent to the firm via email at [email protected]
Quantity in commerce: 160
Distribution: Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
Product codes and lots: UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1369-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1369-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-13

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)