DRG International, Inc.: Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- DRG International, Inc.
- Product
- Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
- Reason / hazard
- Potential for false negative patient results.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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
- Code info
- Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;
- Product quantity
- 211
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Springfield
- State
- NJ
- Country
- United States
- Event id
- 99799
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