BEUDAMED
    FDA Recall Open, Classified

    VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

    Recall: Z-1335-2022 · Initiated June 17, 2022

    Recall

    Recall Number
    Z-1335-2022
    Event Number
    90122
    Firm
    Luminex Corporation
    FEI Number
    3006028115
    Product Code
    PCH
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 17, 2022
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    Description

    VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

    Reason

    There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

    Action

    The firm notified its consignees of the recall by letter on 06/17/2022. The letter explained the issue and provided the following actions be taken: "Customer Action: 1. Please examine your inventory for the affected products, cease all use, and isolate or quarantine them pending disposal. 2. If you currently have any of the identified affected VERIGENE Stool Sample Preparation Kits in your possession (reference Tables 1 & 2 for impacted kit lots), please contact Luminex Global Support Services at [email protected] to arrange for replacement and confirm the disposal of any remaining kits in your inventory per the package insert disposal guidelines. 3. Perform a retrospective review of results for VERIGENE Enteric Pathogens Nucleic Acid test and VERIGENE CDF Nucleic Acid test from 3/25/2021 to11/29/2021. If you have encountered a false negative result with a patient sample tested with kits received during this time frame, please contact Luminex Global Support Services at [email protected] 4. Distribute the notification to any individuals within your organization who need to be made aware of this recall. 5. Please complete the Acknowledgement & Receipt Form and return it to Luminex Technical Support. 6. For those with complaints, questions, or concerns, please contact Luminex Global Support Services at 1-877-785-2323 (U.S. and Canada) or +1-512-381-4397 (Outside U.S. and Canada). 7. Reports can also be made directly to the FDA MedWatch Serious Injury Reporting Program online by completing and submitting the report online at: www.fda.gov/medwatch/report, or by regular mail or Fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178."

    Distribution

    Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.

    Quantity

    5601 units