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    Lia Pregnancy Test

    FDA UDI
    Lia Diagnostics, Inc.·00860000380621·

    Lia Pregnancy Test

    FDA UDI
    Lia Diagnostics, Inc.·00860000380607·

    VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code LTJ·October 1, 2025

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MZO·November 2, 2017

    Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JIT·August 7, 2020

    Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JJX·August 7, 2020

    AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706

    FDA Recall
    Terminated ·Tosoh Smd Inc·Product code CDD·November 15, 2019

    pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).

    FDA Enforcement
    Class II ·Terminated·Sysmex America Inc·November 6, 2013

    AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code KHO·August 23, 2018