BEUDAMED
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    CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

    FDA Recall
    Terminated ·Centers For Disease Control and Prevention·Product code OZE·April 26, 2024

    iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

    FDA Recall
    Terminated ·Conformis, Inc.·Product code LPH·October 16, 2018

    iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

    FDA Enforcement
    Class II ·Terminated·Conformis, Inc.·January 23, 2019

    iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.

    FDA Enforcement
    Class II ·Terminated·Conformis, Inc.·December 2, 2020

    Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.

    FDA Recall
    Terminated ·Conformis, Inc.·Product code LPH·September 21, 2020

    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·March 4, 2015

    MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

    FDA Recall
    Terminated ·Product code LXC·June 28, 2021

    AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.

    FDA Enforcement
    Class II ·Terminated·Sybron Dental Specialties·September 18, 2013

    The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

    FDA Enforcement
    Class II ·Terminated·Nanosphere, Inc.·October 1, 2014

    The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code OCC·October 10, 2013

    VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 2 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 1 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 1 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011

    VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 2 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011

    BC Thrombin Reagent . Thrombin Time Test

    FDA Recall
    Terminated ·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code GJA·July 21, 2004

    Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010

    6 cm Catheter Reservoir with 10 cm extension

    FDA Recall
    Terminated ·Vygon Neuro·Product code HCA·March 24, 2005

    American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016