FDA Enforcement
Class II
Ongoing
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Recall: Z-1923-2026
·
Reported April 29, 2026
Enforcement
- Recall Number
- Z-1923-2026
- Event ID
- 98652
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Remel Europe Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 29, 2026
- Initiation Date
- March 25, 2026
- Classification Date
- April 22, 2026
- Address
- Clipper Boulevard West, Ken, Dartford, N/A, N/A, United Kingdom
Description
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Reason
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.
Code Info
UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858
Distribution
Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.
Quantity
117 US; 950 OUS