FDA DeviceClass IINotable

FDA Recall: Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

Date: 2026-04-29
Brand: Remel Europe Ltd.
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

117 US; 950 OUS

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