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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 FirmJune 12, 2025
Date PostedAugust 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2336-2025
Recall Event ID 97090
510(K)NumberK935013 
Product Classification Radioimmunoassay, estrone - Product Code CGF
ProductEstrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
Code Information Catalog Number DSL8700 UDI Code: 15099590211615 Serial/Lot Numbers: 241014D 241111C 241209C 241209D 250106C 250106D 250203C
Recalling Firm/
Manufacturer		 Immunotech A.S.
Radiova 1
Prague 10 Czech Republic
Manufacturer Reason
for Recall		Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 06/12/2025, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Beckman Coulter determined that the Estrone RIA kit might be affected by an isolated coated tubes inhomogeneity issue causing falsely elevated results or falsely decreased results. Customers are instructed to: Beckman Coulter recommends sharing the content of the Recall Letter with their laboratory and/or medical director regarding the need to review previous patient test results. Note- All affected product have expired (expiry dates 12/31/2024 thru 04/22/2025) For questions, contact Customer Support Center: Website: http://www.beckmancoulter.com Email: imunochem@beckman.com
Quantity in Commerce279 units
DistributionWorldwide - U.S. Nationwide distribution in the states of NC and the countries of Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and Netherlands.
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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