BEUDAMED
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    Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only

    FDA Recall
    Open, Classified ·Cepheid·Product code PGX·April 24, 2023

    Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,

    FDA Recall
    Open, Classified ·Cepheid·Product code PGX·April 24, 2023

    Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique

    FDA Recall
    Open, Classified ·Cepheid·Product code NQX·August 6, 2025

    Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021

    FDA Recall
    Terminated ·Inova Diagnostics Incorporated·Product code DAK·October 28, 2009

    MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code DAK·November 3, 2015

    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (g Eq/ml) can be determined by comparison to a standard curve.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code DAK·April 4, 2017

    GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code GEI·August 6, 2010

    Centrifuge Model CF-6 with lid lock. (Block Model number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Cascade.

    FDA Recall
    Terminated ·Cygnus LLC·Product code JQC·February 4, 2005

    Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Cascade.

    FDA Recall
    Terminated ·Cygnus LLC·Product code JQC·September 8, 2005

    Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.

    FDA Recall
    Terminated ·Salter Laboratories, Division of Regulatory Affairs·Product code CCQ·March 25, 2011

    Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDQ·February 16, 2016

    ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDQ·March 27, 2018

    K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

    FDA Recall
    Open, Classified ·Kamiya Biomedical Company, LLC·Product code CFF·September 28, 2022

    ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CDQ·August 8, 2023

    EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CCQ·April 30, 2013

    V8 Immunodisplacement Kit REF 1803

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code CFF·April 6, 2022

    AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CCQ·April 30, 2013

    IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit)

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code CFF·January 28, 2004

    EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CCQ·April 30, 2013

    Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CDQ·October 3, 2011