CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report
Estrone RIA recalled by Immunotech A.S
Immunotech A.S is recalling Estrone RIA, distributed nationwide in the US. The recall was initiated on 15 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1369-2026
- FDA event ID
- 98219
- Recalling firm
- Immunotech A.S, Prague 10
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Dec 2025
- FDA classified
- 13 Feb 2026
- Reported
- 25 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Dec 2025 | Recall initiated by company | |
| 13 Feb 2026 | Classified by FDA | +60 days |
| 25 Feb 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Estrone RIA, REF: DSL8700
Where it was distributed
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
Where was it sold?
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Immunotech A.S
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Estrone RIA recalled by Immunotech A.S | Immunotech A.S | Other | Nationwide |
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