BEUDAMED
    FDA Enforcement Class II Ongoing

    Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.

    Recall: Z-1424-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1424-2021
    Event ID
    87495
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 21, 2021
    Initiation Date
    March 10, 2021
    Classification Date
    April 13, 2021
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.

    Reason

    When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.

    Code Info

    Lot Numbers: 201334 Exp. 2021-01-21, 210892 Exp. 2021-02-03, 217048 Exp. 2021-02-10

    Distribution

    US Nationwide distribution.

    Quantity

    408 units