BEUDAMED
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    Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.

    FDA Recall
    Terminated ·Caridian BCT, Incorporated·Product code LKN·September 21, 2011

    CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification of E. coli, K. pneumoniae and P. aeruginosa directly from Gram-negative blood cultures

    FDA Recall
    Terminated ·Opgen Inc·Product code LJG·March 18, 2019

    Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc.·Product code KNS·January 4, 2019

    E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media

    FDA Recall
    Terminated ·AdvanDx, Inc.·Product code OAH·June 8, 2010

    AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.

    FDA Recall
    Terminated ·Advandx Inc·Product code JSS·September 14, 2012