BEUDAMED
    FDA Enforcement Class II Ongoing

    PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.

    Recall: Z-2952-2020 · Reported September 23, 2020

    Enforcement

    Recall Number
    Z-2952-2020
    Event ID
    86189
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LONGHORN VACCINES AND DIAGNOSTIC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2020
    Initiation Date
    June 3, 2020
    Classification Date
    September 11, 2020
    Address
    2 Bethesda Metro Cente, N/A, Bethesda, MD, 20814, United States

    Description

    PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.

    Reason

    The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents containing bleach.

    Code Info

    Lot Numbers: 200421A 200421B E200427A E200427B E2000505B CN200423 CN200427

    Distribution

    Nationwide distribution including in the state of MD.

    Quantity

    1,936,050