OVERLOOKED

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Class IIOngoing

DRG International, Inc. recalls Sperm Ab ELISA

Recall date · record updated Oct 14, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
DRG International, Inc.
Reason
Potential for false negative patient results.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99799…

Products

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

    Codes/lots: Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;Quantity: 211Recall no. Z-0082-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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