Quick Facts at a Glance
- Recall Date
- December 15, 2025
- Hazard Level
- HIGH
- Brand
- Immunotech A.S.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Immunotech A.S.
- Product type
- Estrone RIA Kit
- Model numbers
- UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 15, 2025
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- Check the lot number on the kit packaging.
- Verify if the lot number is 251013C or 251110C.
- Confirm the expiration date is before January 27, 2026.
Where to find product info
The lot number and expiration date can typically be found on the product packaging or instruction manual.
What timeline to expect
Expect a 4-6 week processing time for refunds or replacements after following the manufacturer's instructions.
If the manufacturer is unresponsive
- Follow up with the manufacturer using alternative contact methods.
- File a complaint with the FDA if there is no response.
- Document all communication attempts.
How to prevent similar issues
- Always verify the product information and expiration dates before use.
- Consult healthcare professionals for alternative testing options.
- Stay informed about recalls and safety alerts for medical devices.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and any medical records that pertain to the use of the product.
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Product Details
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.
Key Facts
- Recall date: December 15, 2025
- Class II classification
- Distribution: Worldwide including US and Europe
- No injuries reported
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Safety Guide
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