Estrone RIA, REF: DSL8700 recallZ-1369-2026 · Immunotech A.S. · initiated Dec 15, 2025
Class II Open, Classified All recalls posted in February 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Immunotech A.S. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Equipment maintenance
What the company is doing
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]
Recall details
- Recall number
- Z-1369-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Dec 15, 2025
- Posted by the FDA
- Feb 13, 2026
- Recalling firm
- Immunotech A.S.
- Quantity
- 160
- Product code
- CGF
- FDA submissions
- K935013
- Distribution
- Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
Product description
Estrone RIA, REF: DSL8700
Code information (models, lots, serial numbers)
UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Estrone RIA DSL8700IMMUNOTECH s.r.o. · Radioimmunoassay, Estrone3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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