Summary
The FDA issued a Class II for Estrone RIA, REF: DSL8700 by Immunotech A.S.. Reason: The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some .
Details
Source
Device Recall
External ID
Z-1369-2026
Action Date
2026-02-25
Status
Ongoing
Category
device
Product Description
Estrone RIA, REF: DSL8700
Lot/Code Info: UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
Quantity Affected: 160
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.
Distribution
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-15
Company
Prague 10
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 189 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Immunotech A.S. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Immunotech A.S.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Immunotech A.S. have FDA actions?
Immunotech A.S. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1369-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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