BEUDAMED
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    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006

    FDA Recall
    Terminated ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code NQL·November 2, 2017

    NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

    FDA Recall
    Terminated ·Perkinelmer·Product code NQL·November 26, 2012

    Perkin ELmer Life and Analytical Sciences -NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit

    FDA Recall
    Terminated ·Perkin Elmer Life And Analytical·Product code NQL·March 11, 2005

    Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P

    FDA Recall
    Open, Classified ·WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany·Product code HIG·July 17, 2023

    Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·September 3, 2015

    Braun wheelchair lift, model NCL, Braun Corporation, Winamac, IN A wheelchair lift for motor vehicles.

    FDA Recall
    Terminated ·The Braun Corporation·Product code ING·August 15, 2007

    Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

    FDA Recall
    Terminated ·WOM World of Medicine AG Salzufer 8 Berlin Germany·Product code HIG·August 14, 2019

    Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·February 26, 2014

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·March 22, 2016

    Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·January 10, 2014

    NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

    FDA Recall
    Terminated ·Product code MRN·May 3, 2023

    Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent; an in vitro diagnostic primary antibody for use as part of an antibody panel for the classification of tumors of T-cell origin; Catalog No. NCL-L-CD7-580; packaged in 1 mL vials and 0.1 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. NCL-L-CD7-580 is intended for the qualitative identification by light microscopy of CD7 molecules in paraffin-embedded tissue by immunohistochemical staining.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·January 10, 2012

    Truform Therapeutic Classic Medical Style Compression Pantyhose 20-30 mmHG, A Div of SAI, Cincinnati, OH 45209 Product Usage: To help relieve tired, heavy legs, and moderate to pronounced varicose veins and swelling.

    FDA Recall
    Terminated ·Surgical Appliance Industries·Product code FQL·October 7, 2011

    Truform Therapeutic Classic Medical Style Compression Stockings 20-30 mmHG, Truform Therapeutic Classic Medical Style Compression Stockings 30-40 mmHG, A Div of SAI, Cincinnati, OH 45209 Product Usage: To help relieve tired, heavy legs, and moderate to pronounced varicose veins and swelling.

    FDA Recall
    Terminated ·Surgical Appliance Industries·Product code FQL·October 7, 2011

    Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code EQL·December 12, 2016

    Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code EQL·April 6, 2016