Manufacturers

QIAGEN Gaithersburg, Inc.

3 devices in the database

Device Recall Hc2 System Software
  • Model / Serial
    hc2 User's Guide, Lots 5723098 and 5722169; and Qiagen embedded hc2 Software Suite 4.0, Lots Q50455 and Q50349.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The recalled product was sold to medical laboratories nationwide and in Canada.
  • Product Description
    Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. || The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation parameters. The software is used in conjunction with the following QIAGEN products: digene HC2 High-Risk HPV DNA Test [5199-1220 (one-plate); 5199-00016 (four-plate)] digene HC2 HPV DNA Test (5198-1220) digene HC2 CT/GC DNA Test (5130-1220) digene HC2 CT-ID DNA Test (5135-1220) digene HC2 GC-ID DNA Test (5140-1220) digene HC2 CT-GC Dual-ID DNA Test (5145-1220)
Device Recall Qiagen artus CMV RG PCR ASR (Analyte Specific Reagent)
  • Model / Serial
    Catalog Number 4503223, Lot #142345647, Exp: 06/09/14
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.
  • Product Description
    QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) || Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).
Device Recall Qiagen artus CMV RG PCR ASR
  • Model / Serial
    Catalog Number 4503225, Lot #142345648, Exp: 06/09/14 & Lot #142357718 Exp: 06/09/14
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.
  • Product Description
    QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) || Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.