BEUDAMED
    FDA Recall Terminated

    Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

    Recall: Z-0441-2021 · Initiated October 6, 2020

    Recall

    Recall Number
    Z-0441-2021
    Event Number
    86586
    Firm
    Hardy Diagnostics
    FEI Number
    2022807
    Product Code
    PQZ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 6, 2020
    Terminated
    May 28, 2021
    Address
    1430 W McCoy Ln, Santa Maria, CA, 93455-1005

    Description

    Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

    Reason

    Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10

    Action

    Hardy Diagnostic sent a "Urgent: Recall Notification" on 9/30/2020 and sent a follow-up letter 10/06/2020 containing additional information. In addition to notifying consignees about the recall, the firm asked consignees to take the following actions: 1. Please respond to the notification within 10 business days of receipt of the letter, either through mail or email. 2. To respond by email, please scan and send the completed inventory reconciliation form (FORM-2023C) to [email protected]. After a response is received, new labels with the correct expiration date will be sent to you for product that has not yet been used. 3. Upon expiration of the product, on November 10, 2020, discard any remaining stock. This product should be destroyed according to local regulation as non-hazardous waste if un-inoculated or as medical waste if inoculated. 4. Please retain this letter or post the letter where the product is stored to ensure the users are aware of this defect. Additionally, please take the following actions: - Notify any and all employees who may use the product. - If the product was further distributed, notify the consignees the product was distributed to. 5. Any Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htm), by regular mail or by fax. 6. Please feel free to contact Technical Services if you have additional questions about this notification through email (listed above) or through phone call at (800) 266-2222, option 2, Monday through Friday, 8:00 AM to 5:00 PM, Pacific Time.

    Distribution

    US: VA, AR, WI, ID, NY, AL, CA, MT, TX, MN, NH, WA, NC, NY, AZ, AK, MO, FL, MI, WY, ID, CO, AL, MT, WY, Puerto Rico, and Guam

    Quantity

    8,620 units