BEUDAMED
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    BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries).

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code MUQ·April 25, 2014

    BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code MUQ·May 19, 2017

    BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code MUQ·June 4, 2018

    BioGlue Surgical Adhesive, Model BG3510-5-G

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code MUQ·October 7, 2021

    NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·September 29, 2017

    Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·January 18, 2016

    Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017

    Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017

    SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code MVU·May 5, 2017

    Cell Marque CD7 (MRQ-12); Mouse Monoclonal Antibody, Antibody is bottle in HDPE bottle with screw cap lid with container label. Then put in cardboard Box with outer box label. Cell Marque, Rocklin, CA 95677, intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in section of formalin fixed, paraffin embedded tissue section using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist or physician.

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code NJT·January 23, 2012

    INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code MAQ·August 2, 2018

    INFX-8000F Fluoroscopic X-Ray Systems

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code MBQ·December 29, 2017

    Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only.

    FDA Recall
    Terminated ·Digene Corp·Product code MAQ·February 7, 2003

    Coulter DNA Prep Reagents Kit Part 6607055

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code MAQ·October 10, 2003

    Hybrid Capture 2 High-Risk HPV DNA Test, Catalog # 5101-1296

    FDA Recall
    Terminated ·Digene Corp·Product code MAQ·February 7, 2003

    The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system. The cobas x 480 instrument and cobas z 480 analyzer are to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system and analyzer. In the U.S. the cobas z 480 analyzer is used for automated amplification and detection purposes for the following assays: cobas 4800 BRAF V600 Mutation Test cobas Cdiff Test for use on the cobas 4800 System cobas CT/NG v2.0 Test cobas EGFR Mutation Test v2 cobas Factor II and Factor V Test cobas 4800 HPV Test cobas HSV 1 and 2 Test for use on the cobas 4800 System cobas KRAS Mutation Test cobas MRSA/SA Test for use on the cobas 4800 System

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code MAQ·November 19, 2020

    Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only).

    FDA Recall
    Terminated ·Digene Corp·Product code MAQ·February 7, 2003

    CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).

    FDA Recall
    Terminated ·AGFA Corp.·Product code MBQ·September 1, 2006

    Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096

    FDA Recall
    Terminated ·Digene Corp·Product code MAQ·February 7, 2003

    KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas HPV Test include the following liquid based collection media and collection device: " ThinPrep Pap TestTM PreservCyt Solution " Endocervical Brush/Spatula

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code MAQ·July 25, 2013