Estrone diagnostic kits recalled over rare falsely high or low results
Estrone RIA kits, catalog number DSL8700, are recalled because certain lots may rarely give falsely high or falsely low patient results. 279 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice states the kit can produce erroneous patient results with a described potential for injury.
Plain-English summary
The Estrone RIA, catalog number DSL8700, UDI code 15099590211615, is being recalled. It is an in vitro diagnostic manual device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma. Affected lots include 241014D, 241111C, 241209C, 241209D and 250106C, with the full list in the recall notice. The recall covers 279 units distributed in North Carolina and internationally.
The manufacturer states that affected 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, and that the issue may occur only in very rare cases. The FDA classified the action as Class II.
Laboratories should check their stock against the lot numbers in the recall notice and follow the manufacturer's instructions on affected kits and on results already reported.
The recalled product
- Product
- 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.
- Manufacturer
- Immunotech A.S.
- Hazard
- erroneous-results
- in-vitro-diagnostic
- reagent-lot
- class-ii
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22