Estrone RIA recall
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare…
Why was Estrone RIA 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.
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?
Catalog Number DSL8700 UDI Code: 15099590211615 Serial/Lot Numbers: 241014D 241111C 241209C 241209D 250106C 250106D 250203C
- Product
- Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare…
- Recalling firm
- Immunotech A.S.
- Quantity
- 279 units
- 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.
- Recall date
- August 27, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)