BEUDAMED
    278 results · 12ms · Sources: EU EUDAMED, US FDA

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    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·June 6, 2017

    Vaginal Verification Panel Ref 8208 Lot 8208-11

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·January 3, 2020

    SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·August 20, 2021

    Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·March 3, 2022

    Mycoplasma genitalium Control Panel (Inactivated Pellet)

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·February 25, 2022

    SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·August 20, 2021

    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·June 6, 2017

    The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code OHQ·August 1, 2022

    Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·June 6, 2017

    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2C-25C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·June 6, 2017

    Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·July 27, 2022

    Inactivated macrolide and quinolone-resistant Mycoplasma genitalium

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·March 24, 2022

    Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·December 16, 2019

    Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni derived from NCTC 11322, 5. P. shigelloides derived from NCTC 10363, 6. Y. enterocolitica derived from NCTC 11174, 7. E. coli derived from NCTC 11602 (ETEC), 8. V. parahaemolyticus derived from NCTC 13209

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·June 6, 2017

    Inactivated macrolide-resistant Mycoplasma genitalium

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·March 22, 2022

    Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·April 27, 2016

    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems (Schweiz) Ag·September 18, 2013

    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems (Schweiz) Ag·September 18, 2013

    Leica ARveo and M530 OH6 microscope systems.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·June 24, 2020

    Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018