Official recall notice
FDA DeviceClass IINotable
FDA Recall: Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
- Recall date
- 2026-04-29
- Brand
- Remel Europe Ltd.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
117 US; 950 OUS
Product 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.