BEUDAMED
    FDA Recall Open, Classified

    ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

    Recall: Z-2171-2026 · Initiated April 1, 2026

    Recall

    Recall Number
    Z-2171-2026
    Event Number
    98754
    Firm
    Aniara Diagnostica LLC
    FEI Number
    3005017664
    Product Code
    LCO
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    April 1, 2026
    Posted
    May 12, 2026
    Address
    7768 Service Center Dr, West Chester, OH, 45069-2442

    Description

    ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

    Reason

    Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

    Action

    A Field Corrective Action notification letter dated 3/30/26 was sent to customers. Actions implemented by HYPHEN BioMed: -Confirmation of the existence of a flyer discrepancy affecting 95 kits from lot FD1265. - Request for quarantine of the affected kits in US agent warehouse. -Coordination with US agent for notification of the impacted end users. -investigation to define the root cause and to establish corrective and preventive actions. Actions to be implemented by the end user: 1. Check the TAV flyer included in their kit. - If the flyer matches the correct version (dated 18 October 2024) - No action is required. - If the flyer corresponds to the incorrect version (dated I October 2024) - proceed to step 2 2. Destroy the incorrect TAV flyer. The outdated flyer included in the kit must be immediately removed and destroyed, as well as any paper or electronic copy that could have been done in end-user facility, to prevent further use. 3. Replace the incorrect flyer with the corrected version. Use the corrected TAV flyer provided with this notice for all future testing 4. Return the completed and signed form to your local distributor before April 15th, 2026. For any question or information regarding this notification, please contact vigilance team, by email at [email protected].

    Distribution

    US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI

    Quantity

    359 units