Remel Europe Ltd.: Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
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
- Remel Europe Ltd.
- Product
- Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.
- Recall initiated
- 2026-03-25
- Code info
- UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858
- Product quantity
- 117 US; 950 OUS
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Dartford
- State
- N/A
- Country
- United Kingdom
- Event id
- 98652
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