Immunotech A.S. recalled 160 Estrone RIA kits on December 15, 2025, due to a risk of falsely high patient results. This class II recall affects kits distributed in multiple countries, including the US and several European nations.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Immunotech A.S. or your healthcare provider for instructions. Notification method: Letter
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The Estrone RIA kit is a medical device used to measure Estrone hormone levels in patients. Healthcare providers commonly use these kits for hormone testing in various medical assessments.
The recall stems from a potential issue where the kits may produce falsely high Estrone results, which can lead to misdiagnosis or inappropriate treatment. This could cause temporary health issues in rare cases.
This recall is not part of a broader industry pattern.
Consumers should stop using the affected kits immediately to avoid potential misdiagnosis. The risk of harm is considered remote, but healthcare providers should be consulted for alternative testing methods.
The lot number and expiration date can typically be found on the product packaging or instruction manual.
Expect a 4-6 week processing time for refunds or replacements after following the manufacturer's instructions.
Keep all receipts, correspondence with the manufacturer, and any medical records that pertain to the use of the product.
The recalled Estrone RIA kits, reference DSL8700, have lot numbers 251013C (expiration 2025-12-30) and 251110C (expiration 2026-01-27). They were distributed worldwide, including the US, Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, and Italy.
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