BEUDAMED
    FDA Enforcement Class II Ongoing

    Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.

    Recall: Z-1834-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1834-2024
    Event ID
    94454
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Macherey Nagel Gmbh & Co. Kg
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2024
    Initiation Date
    April 4, 2024
    Classification Date
    May 16, 2024
    Address
    Valencienner Str. 11, N/A, Duren, N/A, N/A, Germany

    Description

    Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.

    Reason

    The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can potentially result in the possibility that the parameter leucocytes (a non-specific marker for urinary track infections and an indicator for inflammatory renal processes) is interpreted instrumentally as a false negative. The following HSI item number and lot number were affected: Urispec¿ 11-Way, #102-2285, LOT 65402.

    Code Info

    Product #102-2285, UDI/DI: 00304040001479, LOT 65402.

    Distribution

    US Nationwide distribution in the states of CO, FL, IN, NV, TX.

    Quantity

    5,200 packages