BEUDAMED
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    Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low), Wescor, Inc., 459 South Main Street, Logan, Utah 84321.

    FDA Recall
    Terminated ·Wescor, Inc·Product code JJM·December 26, 2007

    Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321.

    FDA Recall
    Terminated ·Wescor, Inc·Product code JJM·December 26, 2007

    Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop (with Quickie IQ Enhanced Displays)

    FDA Recall
    Terminated ·Sunrise Medical Inc·Product code ITI·April 23, 2007

    SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

    FDA Enforcement
    Class II ·Terminated·Sarken, Inc.·September 4, 2013

    Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP

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

    IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue MX40 Patient Worn Monitors in the USA, to extend the coverage area of a Core Access Point for the wireless Smart-hopping system.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·September 25, 2019

    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·October 26, 2016

    AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.

    FDA Recall
    Terminated ·Ab Sciex·Product code DOP·July 15, 2014

    GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE

    FDA Recall
    Terminated ·Medegen Medical Products, LLC·Product code KCP·April 30, 2003

    Analyst MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP 4500MD LC/MS/MS System, Instrument Part Number: 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Ab Sciex·Product code DOP·February 24, 2016

    AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Ab Sciex·Product code DOP·June 16, 2016

    AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.

    FDA Recall
    Terminated ·Ab Sciex·Product code DOP·March 25, 2016

    AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Ab Sciex·Product code DOP·June 16, 2016

    Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging

    FDA Recall
    Terminated ·Biosound Esaote, Inc.·Product code JOP·June 26, 2014

    Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.

    FDA Recall
    Terminated ·Thermo Finnigan LLC·Product code DOP·July 19, 2016

    Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288

    FDA Recall
    Terminated ·AB SCIEX·Product code DOP·October 4, 2021

    AB SCIEX QTRAP 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Ab Sciex·Product code DOP·June 16, 2016

    AB SCIEX 3200MD QTRAP LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5024500 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Ab Sciex·Product code DOP·June 16, 2016

    MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.

    FDA Recall
    Terminated ·Agilent Technologies, Inc.·Product code DOP·August 15, 2018

    Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

    FDA Recall
    Terminated ·Thermo Fisher Scientific Ratashe 2 Vantaa Finland·Product code DOP·February 1, 2021