FDA-Device2026-10-14Class IIPROCESSING DEFECT
DRG International Sperm Ab ELISA test kit recalled for false negative risk
What this means
DRG International's Sperm Ab ELISA test (model EIA-1826) may return false negative results, meaning it could fail to detect sperm antibodies when they are actually present. This affects lot 320K046 distributed worldwide, including the US and multiple countries in Europe and Asia.
- If you currently use this test kit, contact DRG International for guidance on affected lot numbers and replacement or verification procedures.
- Review any patient results from this lot for potential false negatives and consider retesting if clinically indicated.
The agency's original wording
Hazard
Potential for false negative patient results.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
211
Manufactured in
841 Mountain Ave, N/A, Springfield, NJ, United States
Products
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0082-2027Want us to check the next one for you?
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