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.
- Affected units
- 279
Distribution
Related recalls
Same manufacturer · Immunotech A.S.
See all →- HighEstrone RIA Diagnostic Kit Recall by Immunotech A.S.
FDA (Devices) · 2026-02-25
Same hazard · erroneous results
See all →- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighChemistry analyzer control modules recalled over software that may give erroneous results
FDA (Devices) · 2025-12-24
- HighLaboratory automation recalled over unlabelled or mismatched secondary sample tubes
FDA (Devices) · 2025-12-03
- HighBlood lead test kits recalled over mislabeled calibration buttons
FDA (Devices) · 2025-12-03
- HighLaboratory automation recalled over sample tubes with mismatched labels
FDA (Devices) · 2025-12-03