BEUDAMED
    FDA Enforcement Class II Terminated

    BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).

    Recall: Z-0749-2016 · Reported February 10, 2016

    Enforcement

    Recall Number
    Z-0749-2016
    Event ID
    73027
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 10, 2016
    Initiation Date
    December 24, 2015
    Classification Date
    February 3, 2016
    Termination Date
    December 4, 2017
    Address
    100 Rodolphe St, N/A, Durham, NC, 27712-9402, United States

    Description

    BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).

    Reason

    Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

    Code Info

    Reference number: 259790, Lot number: 1042739, Expiry: 09JAN2016.

    Distribution

    Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.

    Quantity

    2741 units in total