Sperm Ab ELISA recall (DRG International, Inc.)
Medical deviceClass IIOngoing
Summary: DRG International, Inc. is recalling Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);. Reason: Potential for false negative patient results.
What is being recalled
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Why
Potential for false negative patient results.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: New Jersey)
How to tell if yours is affected
Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0082-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 2, 2026 |
| Reported | October 14, 2026 |
| Company | DRG International, Inc. |
| Company location | Springfield, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 211 |
More recalls from DRG International, Inc. · all medical device recalls · recalls from July 2026