Recall Z-1923-2026— Remel Europe Ltd.
Class II · Ongoing
Class II FDA medical device recall by Remel Europe Ltd., initiated 2026-03-25. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Remel Europe Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-25
- Firm location
- Dartford, N/A, United Kingdom
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.