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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

    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

    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

    Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code QOF·March 12, 2025

    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

    Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code QOF·November 8, 2024

    BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·October 22, 2025

    Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·April 1, 2026

    1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code GCJ·January 14, 2022

    8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202

    FDA Recall
    Terminated ·Trilliant Surgical, LLC·Product code HTY·November 4, 2019

    Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

    FDA Recall
    Open, Classified ·Bayer Medical Care, Inc.·Product code DXT·April 24, 2026

    Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

    FDA Recall
    Terminated ·MEDLINE INDUSTRIES, LP Northfield·Product code JIN·March 8, 2022

    Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code NBC·May 22, 2012

    Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code NBC·May 22, 2012

    Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DAP·May 22, 2012

    Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code NBC·May 22, 2012

    Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GHH·May 22, 2012

    nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023