32 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·June 5, 2013
BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTO·April 12, 0013
CT Goldseal BrightSpeed 16 PWR TIO 2 YR
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·May 24, 2018
CT Goldseal BrightSpeed 16 PWR TIO 2 YR
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
FDA Enforcement
Class I
·Terminated·Beckman Coulter Inc.·November 28, 2018
Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.
FDA Recall
Terminated
·Coloplast Manufacturing US, LLC·Product code FAF·April 30, 2010
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019
Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.
FDA Recall
Terminated
·Sysmex America, Inc.·Product code PER·July 6, 2020
Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
FDA Recall
Terminated
·Diagnostic Products Corp·Product code LYR·July 31, 2003
Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code PER·May 22, 2017
BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019
H. Pylori IgM ELISA 96 Well Kit, Catalog Number: HP015M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
FDA Recall
Terminated
·Calbiotech Inc·Product code LYR·August 27, 2008
H. Pylori IgA ELISA 96 Well Kit, Catalog Number: HP014A The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
FDA Recall
Terminated
·Calbiotech Inc·Product code LYR·August 27, 2008
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code PDR·May 13, 2015
BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019
H pylori IgG ELISA kit (Qualitative) H pylori IgG ELISA kit (Quantitive) H pylori IgG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
FDA Recall
Terminated
·BioCheck Inc·Product code LYR·December 22, 2010
Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.
FDA Recall
Terminated
·Meridian Bioscience Inc·Product code LYR·December 26, 2002
Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers (FC500, Navios and Navios EX). The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code PER·May 22, 2017
"***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14g, 6"***Plainsboro, NJ***" Needle for lumbar peritoneal shunt
FDA Recall
Terminated
·Integra Neurosciences PR, Inc. Carr·Product code JXG·November 28, 2011
"***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***Plainsboro, NJ***" Collars for lumbar peritoneal shunt
FDA Recall
Terminated
·Integra Neurosciences PR, Inc. Carr·Product code JXG·November 28, 2011