BEUDAMED
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    N Latex CDT Kit

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·September 5, 2018

    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·April 29, 2020

    N Latex CDT Kit

    FDA Recall
    Terminated ·CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany·Product code NAO·May 31, 2018

    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

    FDA Recall
    Terminated ·CSL Behring GmbH Emil-Von-Behring-Str. 76 Marburg Germany·Product code NAO·March 2, 2020

    Misys Laboratory versions 5.2, 5.23, or 5.3 with ADT Interface to CoPathPlus.

    FDA Recall
    Terminated ·Sunquest Information Systems·Product code JQP·October 24, 2002

    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·June 28, 2017

    Merge PACS software. The firm name on the label is Merge Healthcare.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 15, 2017

    CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018

    The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.

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

    Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·September 10, 2014

    Medtronic SynchroMed implantable drug pump Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, 8566 The Model 8551, 8555, 8561, 8562, 8564, 8565, and 8566 Refill Kits are intended for use in refilling Medtronic implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps

    FDA Recall
    Terminated ·Medtronic, Inc. Neuromodulation·Product code LKK·January 14, 2011

    LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Distributed by Siemens, Concord, CA Mfg by Impac Medical Systems, Sunnyvale, CA Electronic patient records management system

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LMB·March 23, 2011

    Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JQP·July 31, 2014

    Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.

    FDA Recall
    Terminated ·Medtronic, Inc. Neuromodulation·Product code LKK·January 14, 2011

    Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.

    FDA Enforcement
    Class III ·Terminated·Nanosphere, Inc.·August 20, 2014

    DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code MHY·March 17, 2017

    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·May 24, 2017

    Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: " Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain Preservative-free sterile saline, USP, can be used to achieve the physician prescribed concentration of preservative-free morphine sulfate sterile solution. " Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain Preservative-free sterile saline, USP, can only be used to achieve the physician prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. " Chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen injection). " Chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency.

    FDA Recall
    Terminated ·Medtronic, Inc. Neuromodulation·Product code LKK·January 14, 2011

    OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    FDA Recall
    Terminated ·Skeletal Kinetics, Llc·Product code GXP·June 6, 2019