Device recall

Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);

FDA recall source

Recall number

Z-0082-2027

Event id

99799

Status

Ongoing

FDA classification

Class II

Recalling firm

DRG International, Inc.

Report date

Oct 14, 2026

Posted

Oct 2, 2026

Initiated

Jul 2, 2026

Center classification date

Oct 2, 2026

Product code

DFQ

Device type

Sperm, Antigen, Antiserum, Control

Reason

Potential for false negative patient results.

Root cause

Reprocessing Controls

Quantity

211

Code info

Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;

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.

Voluntary or mandated

Voluntary: Firm initiated

Location

Springfield, NJ, United States