FDAFDA recall Z-0082-2027 · Oct 14, 2026
DRG International, Inc.: Sperm Ab ELISA recall
Recall found
Product
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Reason for recall
Potential for false negative patient results.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;
- Quantity
- 211
- 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.
- Recalling firm
- DRG International, Inc., Springfield, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-02
Source: openFDA enforcement record Z-0082-2027 · search recall number Z-0082-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.