Estrone RIA recall
Estrone RIA, REF: DSL8700
Why was Estrone RIA 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
- Product
- Estrone RIA, REF: DSL8700
- Recalling firm
- Immunotech A.S.
- Quantity
- 160
- Distribution
- Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
- Recall date
- February 25, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)