BEUDAMED
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    Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code NHX·July 16, 2019

    Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)

    FDA Recall
    Terminated ·Product code NHX·November 11, 2005

    Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments. [Note: the Atellica IM anti-CCP IgG (aCCP) assay was introduced for sale through the Replacement Reagent Policy.]

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NHX·August 14, 2019

    Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code NHX·July 16, 2019

    EliA Sample Diluent, Article number, 83-1023-01

    FDA Recall
    Terminated ·Phadia US Inc·Product code NHX·January 30, 2017

    Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.

    FDA Recall
    Terminated ·Euro Diagnostica AB·Product code NHX·February 14, 2016

    Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195

    FDA Recall
    Terminated ·Kendall Healthcare Products Co·Product code MPB·December 2, 2003

    Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192

    FDA Recall
    Terminated ·Kendall Healthcare Products Co·Product code MPB·December 2, 2003

    Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm on label: Tyco Healthcare, Mansfield, MA. Product sold sterile, 10 units per case.

    FDA Recall
    Terminated ·Kendall Healthcare Products Co·Product code LJS·April 27, 2005

    AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·October 17, 2018

    AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

    FDA Enforcement
    Class II ·Terminated·RANDOX LABORATORIES, LTD.·September 23, 2020

    AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

    FDA Enforcement
    Class II ·Terminated·RANDOX LABORATORIES, LTD.·September 23, 2020

    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·March 7, 2018

    Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

    FDA Enforcement
    Class II ·Terminated·NOX MEDICAL·October 13, 2021

    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·November 4, 2015

    Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

    FDA Recall
    Terminated ·NOX MEDICAL Keldnaholt Reykjavik Iceland·Product code MNR·September 7, 2021

    Varian High Energy Linear Accelerator, C-Series Clinac, Reference/FSCA Identifier: CP-06611; Models Numbers: 600C, 600CD, 6EX, DBX, 2100C, 2100CD, 2300CD, 21EX, 23EX, DMX, DHX versions 2.x through 6.x; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·November 28, 2011

    VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·August 20, 2014

    Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

    FDA Enforcement
    Class II ·Terminated·Southern Implants, Inc·December 4, 2013