- Recalling firm
- Remel Europe Ltd.
- Reason for recall
- Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
- Affected products (lot / model / serial)
- UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858
- Units affected
- 117 US; 950 OUS
- Distribution pattern
- Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.
- Firm location
- Dartford, N/A, United Kingdom
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1923-2026
- Recall initiated
- March 25, 2026
- FDA classification date
- April 22, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98652
- Last updated on HTM Vibe
- July 24, 2026