- Recalling firm
- DRG International, Inc.
- Reason for recall
- Potential for false negative patient results.
- Affected products (lot / model / serial)
- Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;
- Units affected
- 211
- Distribution pattern
- 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.
- Firm location
- Springfield, NJ, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0082-2027
- Recall initiated
- July 2, 2026
- FDA classification date
- October 2, 2026
- FDA report date
- October 14, 2026
- FDA event ID
- 99799
- Last updated on HTM Vibe
- October 21, 2026
