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Open, Classified

Estrone RIA, REF: DSL8700

FDA Recall Z-1369-2026 · Posted 2026-02-13

Recalling FirmImmunotech A.S.
Recall StatusOpen, Classified
Product CodeCGF
Date Initiated2025-12-15
Product Quantity160

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.

Firm 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]

Root Cause

Equipment maintenance

Distribution Pattern

Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935013DSL ESTRONE (DSL 8700)Diagnostic Systems Laboratories, Inc. · 1994-06-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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