BEUDAMED
    FDA Enforcement Class II Ongoing

    Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004

    Recall: Z-0259-2025 · Reported November 6, 2024

    Enforcement

    Recall Number
    Z-0259-2025
    Event ID
    95439
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Princeton Biomeditech Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2024
    Initiation Date
    August 23, 2024
    Classification Date
    October 30, 2024
    Address
    4242 US Highway 1, N/A, Monmouth Junction, NJ, 08852-1905, United States

    Description

    Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004

    Reason

    This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples.

    Code Info

    UDI-DI: 00742860100208 Lot Number: 563L13

    Distribution

    US Distribution to MO only.

    Quantity

    1,860 kits (50,220 test devices)