Estrone RIA Diagnostic Kit Recalled for Potentially Inaccurate Test Results
Immunotech is recalling 279 units of the Estrone RIA diagnostic kit due to rare instances where test results may be falsely high or low, which might cause temporary or permanent injury.
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: FDA Class II recall with no reported illnesses or injuries to date. The hazard is theoretical—potentially inaccurate test results with remote probability of causing temporary or permanent injury—but no actual patient harm has been documented. Per the rubric, risk-of-harm products without reported injuries score 3.
Plain-English summary
Immunotech A.S. is recalling 279 units of the Estrone RIA diagnostic kit (Catalog Number DSL8700, UDI Code: 15099590211615). Affected lot numbers are 241014D, 241111C, 241209C, 241209D, 250106C, 250106D, and 250203C.
The Estrone RIA is an in vitro diagnostic device used by healthcare professionals to measure estrone levels in human serum and plasma. In rare cases, the kit may produce falsely high or falsely low test results. Falsely high results might cause temporary injury with remote probability; falsely low results might cause permanent injury with remote probability.
Healthcare facilities and laboratories using affected lot numbers should discontinue use immediately and contact their supplier for replacement kits. Patients tested with affected kits should consult with their healthcare provider about the potential for inaccurate test results.
The recalled kits were distributed in North Carolina and internationally in Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and the Netherlands.
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
- inaccurate-test-results
- false-measurement
Distribution
Distributed nationwide across the United States.
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