Remel Europe Ltd.: Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Recall Summary Remel Europe Ltd. is recalling Oxoid Agglutinating Sera, Salmonella 9-0 (lot R30957301) because affected batches are showing cross-reactions with a different Salmonella type (2-0) within 60 seconds, which could cause laboratory technicians to misidentify one Salmonella strain as another. This product is a laboratory testing device distributed nationwide across the U.S. The recall is classified as Class II, indicating the product could cause incorrect test results but poses no direct harm to consumers.
- Recalling firm
- Remel Europe Ltd.
- 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
- U.S. Food and Drug Administration
- Recall date
- 2026-03-25
- Status
- Ongoing
- 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 U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/a634913d-1f0d-4b92-a10e-9f2ff57acd65