HIGH

Immunotech A.S. Recalls Estrone RIA Kit Over False Results Hazard

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.

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

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

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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.

The Hazard

The affected Estrone RIA kit lots may occasionally produce falsely high Estrone results. Such inaccuracies could lead to temporary health issues in rare cases.

Reported Incidents

There have been no reported injuries or incidents associated with this recall. The manufacturer classified the risk as high but indicated that the likelihood of harm is remote.

What to Do

Stop using the Estrone RIA kits immediately. Follow the manufacturer’s recall instructions and contact Immunotech A.S. or your healthcare provider for further guidance.

Contact Information

For assistance, reach out to Immunotech A.S. via their official website or contact your healthcare provider.

Key Facts

  • Recall date: December 15, 2025
  • Class II classification
  • 160 units recalled
  • Distribution: Worldwide including US and Europe
  • No injuries reported

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI: 15099590211615
251013C(2025-12-30)
251110C(2026-01-27)
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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