BEUDAMED
    FDA Recall Terminated

    RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

    Recall: Z-0422-2022 · Initiated November 9, 2021

    Recall

    Recall Number
    Z-0422-2022
    Event Number
    89041
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    JSS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 9, 2021
    Terminated
    February 10, 2025
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

    Reason

    There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.

    Action

    bioMerieux in the U.S. issued an Urgent Field Safety Notice dated November 2021 on 11/9/2021 via email for delivery to the Lab Director or Lab Manager. The notice described the issue, impact to the customer, and listed the required customer actions: Distribute the information to all appropriate personnel in their laboratory and forward the information to all parties that may use the product, including others to whom the product may have been transferred. The customer is informed they can continue to use RAPID 20 E, however, they must refer to the following Reading Table or to the corrected RAPID 20 E package insert version "G1" available on Resource Center when reading the CIT test result. For tests previously performed using RAPID 20 E, the customer is strongly recommended that they identify any possible misidentifications to analyze the related risks and to determine appropriate actions, if relevant. An Acknowledgement Form was enclosed to confirm receipt of the notice.

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, and WI. There was government distribution but no military distribution.

    Quantity

    1,043 units