# Class II recall Z-0082-2027: DRG International, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0082-2027 |
| Recalling firm | DRG International, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Sperm Ab ELISA;  Model/Catalog Number: EIA-1826;  Product Description: Sperm Ab ELISA (96 well plate test); |
| Reason | Potential for false negative patient results. |
| 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. |
| Recall initiated | 2026-07-02 |
| Reported | 2026-10-14 |
| Firm location | Springfield, NJ, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 22 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0082-2027%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.