BEUDAMED
    FDA Enforcement Class II Ongoing

    HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.

    Recall: Z-0224-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0224-2020
    Event ID
    83853
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hycor Biomedical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2019
    Initiation Date
    July 25, 2018
    Classification Date
    October 29, 2019
    Address
    7272 Chapman Ave, Garden Grove, CA, 92841-2103, United States

    Description

    HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.

    Reason

    Some of the Stop Solution bottles, a caustic solution, have been reported to leak.

    Code Info

    Stop Solution bottles, REF 308051 - Lot numbers 154803, exp. 31-MAR-2021; and 154144, exp. 30-SEP-2020; HYTEC Specific & Total IgE Kit, REF 74155, Lot numbers 154104-11, exp. 30-SEP-2018; and 156932-1, exp. 30-JUN-2018 - all contain Stop Solution lot 154803; HYTEC Specific & Total IgE Kit, REF 74155, Lot numbers 154104-10, exp. 30-SEP-2018; 154104-7, exp. 30-SEP-2018; 154104-8, exp. 30-SEP-2018; and 154104-9, exp. 30 SEP-2018 - all contain Stop Solution lot 154144; and HYTEC Specific IgG EIA ref 74114, Lot number 155324, exp. 31-DEC-2018 - contains Stop Solution lot 154144.

    Distribution

    Stop Solution bottles were distributed to AL, CA, FL, IL, KS, LA, MS, NJ, NY, SC, TX, WA, and to the U.S. Virgin Islands. Foreign distribution of the bottles was made to Germany. There was no government/military distribution. Assay kits containing the Stop Solution bottles were distributed to FL and to the following foreign countries: Austria, Denmark, France, Germany, Greece, Italy, Kuwait, Netherlands, Russia, Spain, and United Kingdom.

    Quantity

    185 individual bottles (170 US and 15 OUS) and 1,298/1-bottle kits (OUS)