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U.S. Department of Health and Human Services

Class 2 Device Recall Estrone RIA

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 Class 2 Device Recall Estrone RIAsee related information
Date Initiated by FirmDecember 15, 2025
Date PostedFebruary 13, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1369-2026
Recall Event ID 98219
510(K)NumberK935013 
Product Classification Radioimmunoassay, estrone - Product Code CGF
ProductEstrone RIA, REF: DSL8700
Code Information UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
Recalling Firm/
Manufacturer		 Immunotech A.S.
Radiova 1
Prague 10 Czech Republic
Manufacturer 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.
FDA Determined
Cause 2		Equipment maintenance
ActionOn 12/15/2025, Beckman Coulter emailed recall notices to customers who were informed of the following: 1) Discard any remaining inventory of affected lots per your laboratory protocols and ask for replacement. 2) Firm recommends sharing the content of this letter with your laboratory and/or medical director. 3) If you have forwarded any of the affected products to another laboratory, provide them a copy of this letter. 4) Complete and return the response form via email to QACZ@beckman.com Questions can be sent to the firm via email at imunochem@beckman.com
Quantity in Commerce160
DistributionWorldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CGF
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