BEUDAMED
    FDA Recall Open, Classified

    Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

    Recall: Z-1923-2026 · Initiated March 25, 2026

    Recall

    Recall Number
    Z-1923-2026
    Event Number
    98652
    Firm
    Remel Europe Ltd. Clipper Boulevard West Ken Dartford United Kingdom
    FEI Number
    3003750284
    Product Code
    GRM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 25, 2026
    Posted
    April 22, 2026

    Description

    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.

    Action

    Firm began notifying consignees on March 25, 2026 via letters titled "Urgent: Medical Device Recall." Laboratory professionals are advised to review results and destroy any remaining inventory of affected lots. Affected lots should not be used for any clinical laboratory testing. Customers should complete and return the included acknowledgement form for replacement/credit to be processed. Notice should be passed on to all who need to be aware. Firm is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.

    Distribution

    Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.

    Quantity

    117 US; 950 OUS