223 results
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22ms
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Sources: EU EUDAMED, US FDA
ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code MYA·May 16, 2011
iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code MYA·May 16, 2011
Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No. DS9800; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. Intended for immunohistochemistry on paraffin-embedded tissue sections.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code NJT·November 16, 2010
iVIEW DAB Detecion Kit. Catalog Number 760-091
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code KTO·May 7, 2003
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006
Portex Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·September 23, 2013
Portex Saddleblock Tray with Drugs 25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·September 23, 2013
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code CAZ·August 23, 2013
EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) ASK-03001-KC, ASK-03001-KC1 and HH-03000. Epidural anesthesia kit
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·October 29, 2010
ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH, ASK-04001-SUH and ASK-04001-UHC. Access tray for epidural anesthesia kit
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·October 29, 2010
EPIDURAL CATHETERIZATION KIT with FlexTip Plus(R) CATHETER/Product SKU (Code) NH-05501. Anesthesia conduction kit
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·October 29, 2010