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CLASS II · ModerateFDA

DRG International, Inc. recalls Sperm Ab ELISA

📅 Jul 2, 2026 · 📍 Nationwide
Recalling company
DRG International, Inc.
Product
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Reason
Potential for false negative patient results.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jul 2, 2026
Reported
Oct 14, 2026
Distribution
Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.
Status
Ongoing
Quantity
211
Lot / codes
Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;
Company location
Springfield, NJ
Recall type
Voluntary: Firm initiated
Recall number
Z-0082-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0082-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.