BEUDAMED
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    CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

    FDA Enforcement
    Class II ·Terminated·CSA Medical·April 29, 2015

    MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

    FDA Enforcement
    Class II ·Terminated·Medistim Asa·March 7, 2018

    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

    FDA Enforcement
    Class II ·Terminated·CSA Medical·January 14, 2015

    LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233

    FDA Recall
    Terminated ·Esa Biosciences, Inc.·Product code DOF·May 19, 2005

    ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142

    FDA Recall
    Terminated ·Esa Biosciences, Inc.·Product code DOF·September 20, 2007

    ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762

    FDA Recall
    Terminated ·Esa Biosciences, Inc.·Product code DOF·September 20, 2007

    MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

    FDA Recall
    Terminated ·Medistim Asa Okernveien·Product code DPW·April 25, 2017

    Post Medical Valves VO870A-Y and VO870-A-Y-T PSI 2015, PSI 2015, CGA 870, Inlet .750 STDS, Gas services (Oxygen), PSI 2015, Aluminum Cylinders, InterMed Gas Products LLC Industrial Division, 2056 Vista Parkway West Palm Beach, FL 33411.

    FDA Recall
    Terminated ·Intermed Gas Products Corporation·Product code ECX·March 27, 2009

    On Site Gas Systems POGS 33C Portable Oxygen Generation System

    FDA Recall
    Terminated ·On Site Gas Systems Inc.·Product code CAW·December 19, 2013

    On Site Gas Systems POGS 33C Portable Oxygen Generation System

    FDA Enforcement
    Class II ·Terminated·On Site Gas Systems Inc.·January 15, 2014

    MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

    FDA Enforcement
    Class II ·Terminated·Linde Gas North America Llc·June 26, 2013

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Enforcement
    Class II ·Terminated·Paa Laboratories Inc·July 24, 2013

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Recall
    Terminated ·Paa Laboratories Inc 145 Bethridge Road Etobicoke Canada Ontario·Product code KIS·April 12, 2013

    7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code DCF·October 14, 2019

    Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code KSG·October 14, 2019

    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

    FDA Recall
    Terminated ·Product code GEH·November 10, 2014

    Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.

    FDA Recall
    Terminated ·Abbott Molecular·Product code MVU·December 22, 2006

    MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

    FDA Recall
    Terminated ·Linde Gas North America Llc 575 Mountain Ave Attn Import Compliance Manager New Providence NJ 07974·Product code CAN·March 8, 2013

    Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 28, 2014

    Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MKW·March 19, 2014