BEUDAMED
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    DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.

    FDA Recall
    Open, Classified ·Nuclein LLC·Product code QOF·June 25, 2025

    Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V

    FDA Recall
    Open, Classified ·Wondfo USA Co Ltd·Product code GTY·April 22, 2024

    SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJX·April 24, 2025

    Diagnostic Kit SARS-cCo V Antigen Rapid Test

    FDA Recall
    Open, Classified ·USA Medical, LLC·Product code QKP·April 4, 2022

    Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

    FDA Recall
    Open, Classified ·Lusys Laboratories, Inc.·Product code QKP·January 13, 2022

    Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

    FDA Recall
    Open, Classified ·Jiangsu Well Biotech Co., Ltd. No·Product code QKP·August 9, 2022

    LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

    FDA Recall
    Open, Classified ·Lusys Laboratories, Inc.·Product code QKP·January 13, 2022

    COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

    FDA Recall
    Open, Classified ·Lusys Laboratories, Inc.·Product code QKO·January 13, 2022

    FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QBH·May 8, 2023

    BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·May 8, 2023

    FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·March 8, 2023

    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QBH·December 14, 2023

    FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·January 26, 2024

    In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·February 1, 2023

    FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·April 25, 2023

    The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·November 27, 2023

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PEN·June 19, 2024

    In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PEN·February 1, 2023

    BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QDS·June 10, 2024

    In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·February 1, 2023