BEUDAMED
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    MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.

    FDA Enforcement
    Class II ·Terminated·DiaSorin Molecular LLC·July 22, 2020

    Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air within the IV infusion set. While it is not listed in the labeling, it is known that the filter is used for removal of particulate matter for some medications and at risk patient populations.

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·July 4, 2018

    HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.

    FDA Enforcement
    Class II ·Terminated·Life Technologies Corporation·September 4, 2013

    BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)

    FDA Enforcement
    Class I ·Terminated·Becton Dickinson & Company·March 28, 2018

    BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894)

    FDA Enforcement
    Class I ·Terminated·Becton Dickinson & Company·March 28, 2018

    BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50382903680400); 5. 366667 (UDI: 50382903666671); 6. 367880 (UDI: 50382903678803)

    FDA Enforcement
    Class I ·Terminated·Becton Dickinson & Company·March 28, 2018

    BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI: 50382903678568); 8. 367861 (UDI: 50382903678612); 9. 367862 (UDI: 50382903678629); 10. 367863 (UDI: 50382903678636); 11. 368021 (UDI: 50382903680219); 12. 368047 (UDI: 50382903680479); 13. 368054 (UDI: 50382903680547); 14. 368661 (UDI: 50382903686617); 15. 364300 (UDI: pre-UDI)

    FDA Enforcement
    Class I ·Terminated·Becton Dickinson & Company·March 28, 2018

    EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound, Inc.·December 24, 2014

    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·February 9, 2022

    ARIES HSV 1&2 Assay, Part Number/REF 50-10017

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·January 26, 2022

    Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound, Inc.·December 24, 2014

    Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·March 24, 2021

    Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·February 20, 2013

    Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·February 17, 2016

    216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·April 26, 2017

    Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·October 21, 2020

    Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class I ·Terminated·Focus Diagnostics Inc·April 13, 2016

    PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module directions for Use for complete loading and operating instructions. Notes: The set should be changed according to the facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 14, 2018

    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

    FDA Enforcement
    Class II ·Terminated·BD SWITZERLAND SARL·May 20, 2020

    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

    FDA Enforcement
    Class II ·Terminated·BD SWITZERLAND SARL·May 20, 2020