BEUDAMED
    FDA Recall Open, Classified

    Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics

    Recall: Z-1975-2023 · Initiated May 2, 2023

    Recall

    Recall Number
    Z-1975-2023
    Event Number
    92297
    Firm
    Helena Laboratories, Corp.
    FEI Number
    1618982
    Product Code
    LXG
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    May 2, 2023
    Posted
    June 16, 2023
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131

    Description

    Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics

    Reason

    Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.

    Action

    On April 27, 2023, Helena Laboratories contacted consignees via phone to make them aware of the recall. On May 2, 2023, Helena Laboratories followed up by issuing an Urgent Medical device Recall notification via E-Mail. Helena Laboratories asks consignees to take the following actions: 1. Carefully open each box while wearing gloves. Do not touch the teeth of the applicator as this can affect its use during sample delivery. 2. Locate the number imprinted on the handle of the applicator. The number may face outward or inward depending on the placement in the box. Incorrect applicators are imprinted with the number 18. 3. Remove and discard any boxes with applicators imprinted with the number 18. If the applicator is imprinted with the number 12, mark the box to indicate that it has been examined and contains the correct product. 4. Notate the total number of boxes inspected on the attached form. Affected products will be credited or replaced. 5. If you have further distributed this product, please identify your customers and notify them at once of this recall. Your notification to your customers may include a copy of this recall notification letter. This recall should be carried out at the user level. 6. Please complete and return the enclosed Acknowledgement and Receipt Form to [email protected] or mail.

    Distribution

    Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.

    Quantity

    32 units