FDA recall Z-1923-2026

Remel Europe Ltd. · Class II · device

Product

Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

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.

Key facts

Status
Ongoing
Initiation date
2026-03-25
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dartford, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1923-2026