Remel Europe Ltd.: Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

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.

Details from the source

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. Quantity: 117 US; 950 OUS Lot/code info: UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858

UPC codes

05056080500270

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.