FDA-Device2026-02-25Class IIPROCESSING DEFECT
Immunotech Estrone RIA kit (DSL8700) recalled for rare falsely high results
What this means
Immunotech's Estrone RIA diagnostic kit may rarely produce falsely high hormone test results in patients. This could potentially lead to unnecessary or incorrect medical decisions. The issue affects only specific lot numbers and occurs very infrequently.
- If you use Estrone RIA kit lot 251013C (expires 2025-12-30) or 251110C (expires 2026-01-27), stop using it immediately
- Contact Immunotech or your supplier about replacement kits or instructions
- Review any patient test results from these lots with your healthcare provider or laboratory director
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
Affected count
160
Manufactured in
Radiova 1, Prague 10, Czech Republic
Products
Estrone RIA, REF: DSL8700
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2026Want us to check the next one for you?
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