Estrone RIA Catalog Number DSL8700 recallZ-2336-2025 · Immunotech A.S. · initiated Jun 12, 2025
Open, Classified
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
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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]
Recall details
- Recall number
- Z-2336-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 12, 2025
- Posted by the FDA
- Aug 18, 2025
- Recalling firm
- Immunotech A.S.
- Quantity
- 279 units
- Product code
- CGF
- FDA submissions
- K935013
- 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 description
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.
Code information (models, lots, serial numbers)
Catalog Number DSL8700 UDI Code: 15099590211615 Serial/Lot Numbers: 241014D 241111C 241209C 241209D 250106C 250106D 250203C
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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