Warning
Remel Europe Ltd. Recalls Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1923-2026Medical Device
Remel Europe Ltd. Recalls Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Remel Europe Ltd. · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. Remel Europe Ltd. initiated the recall on March 25, 2026 affecting 117 US; 950 OUS. Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. The product was distributed internationally, including the United States. Consumers should check their purchases and discontinue use of any affected product. Contact Remel Europe Ltd. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.