BEUDAMED
    FDA Recall Terminated

    LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299

    Recall: Z-0713-2022 · Initiated October 6, 2014

    Recall

    Recall Number
    Z-0713-2022
    Event Number
    89451
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 6, 2014
    Terminated
    January 17, 2023
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299

    Reason

    This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.

    Action

    Microbiologics notified customers on about 10/06/2014 via letter titled "E.faecalis Gentamicin Susceptibility Notification." Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall, it is recommended that the intended use of the organism be reviewed to determine if Gentamicin synergy results have an impact on use. It is recommended to discard these lots if an impact is to be expected. Questions or concerns can be directed to the Technical Support team at 320.229.7064 or [email protected].

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, United Arab Emirates, and Vietnam.

    Quantity

    153 units