BEUDAMED
    FDA Recall Terminated

    BacT/ALERT FA, bioMrieux, 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-0750-2016 · Initiated December 24, 2015

    Recall

    Recall Number
    Z-0750-2016
    Event Number
    73027
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 24, 2015
    Terminated
    December 4, 2017
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    BacT/ALERT FA, bioMrieux, 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.

    Action

    Biomerieux sent a Product Recall Notice letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the referenced part and lot number and discard remaining inventory according to their facility's procedure for culture media. Customers were also instructed to contact their local bioMrieux representative for product replacement.

    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