DRG International Sperm Ab ELISA
Potential for false negative patient results.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
DRG International, Inc. recalled Sperm Ab ELISA, a 96 well plate test, due to a potential for false negative patient results. The recall began July 2, 2026, and was added to the FDA's Enforcement Report and classified on October 2, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
Sperm Ab ELISA
- Model
- EIA-1826
- UDI-DI
- 04048474018264
- Lot
- 320K046
Details
- Company began the recall
- Event ID
- 99799
- Company
- DRG International, Inc.
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
