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Recall Observatory FDA recall evidence

Device product

Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

Z-1923-2026

March 25, 2026

Class II

Product summary

Firm
Remel Europe Ltd.
Event
Event 98652
Status
Ongoing
Classification
Class II
Quantity
117 US; 950 OUS
Official record key
device-enforcement:Z-1923-2026

Official wording

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 information: UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.