BEUDAMED
    FDA Enforcement Class II Terminated

    GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.

    Recall: Z-0348-2023 · Reported December 7, 2022

    Enforcement

    Recall Number
    Z-0348-2023
    Event ID
    91078
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greer Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 7, 2022
    Initiation Date
    October 25, 2022
    Classification Date
    November 30, 2022
    Termination Date
    February 11, 2026
    Address
    639 Nuway Cir, Lenoir, NC, 28645-3646, United States

    Description

    GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.

    Reason

    The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted.

    Code Info

    Lot Number 389592, exp 6/12/2023

    Distribution

    US Distribution to states of: CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA, and International to countries of: Canada, Denmark

    Quantity

    102 units