BEUDAMED
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    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

    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

    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

    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 1, 2015

    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 8, 2015

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054

    FDA Recall
    Terminated ·LumiQuick Diagnostics Inc.·March 4, 2014

    #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·July 6, 2022

    The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code MDS·July 15, 2020

    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    MAC VU360, Electrocardiograph

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 16, 2020

    (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQO·January 14, 2004

    Bio-MAC Cannula (Needle) Set

    FDA Enforcement
    Class II ·Terminated·Biologic Therapies, Inc·April 8, 2015

    MAC VU360, Model Number 2030360-001, Electrocardiograph

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 31, 2019