Remel Europe Ltd. Clipper Boulevard West Ken Dartford United Kingdom: Antisera, All Groups, Salmonella Spp.
- Recalling firm
- Remel Europe Ltd. Clipper Boulevard West Ken Dartford United Kingdom
- Product
- Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-25
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/7bd937af-a946-485d-958f-6ab62e139f4f