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U.S. Department of Health and Human Services

Class 2 Device Recall Sperm Ab ELISA

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 Class 2 Device Recall Sperm Ab ELISAsee related information
Date Initiated by FirmJuly 02, 2026
Date PostedOctober 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0082-2027
Recall Event ID 99799
Product Classification Sperm, antigen, antiserum, control - Product Code DFQ
ProductSperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Code Information Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;
FEI Number 2245285
Recalling Firm/
Manufacturer		 DRG International, Inc.
841 Mountain Ave
Springfield NJ 07081-3437
For Additional Information ContactIna Hairston (US Agent for DRG Instruments)
973-5647555
Manufacturer Reason
for Recall		Potential for false negative patient results.
FDA Determined
Cause 2		Reprocessing Controls
ActionOn July 2, 2026 Field Safety Notice letters were sent to customers. Actions to be taken: Please check your stocks for the lot in question (320K046), stop using these kits immediately and quarantine these products without delay. Please destroy the kits and send us the confirmation with the completed response form. If you have transferred any of the affected products to another laboratory, please provide them with a copy of this letter.
Quantity in Commerce211
DistributionWorldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.
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.
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