Class II

Medical Device Recall: Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

Remel Europe Ltd. · March 25, 2026

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.

Distribution

Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.

States Affected

NATIONWIDE

Quantity Affected

117 US; 950 OUS

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1923-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.