Official recall notice
FDA DeviceClass IINotable
Sperm Ab ELISA Recall (Oct 2026) – DRG International
Product: Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
- Recall date
- 2026-10-14
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential for false negative patient results.
Product description
Potential for false negative patient results.
Affected products
Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;