Device Recall VITROS Chemistry Products

  • Modelo / Serial
    GEN 3773, Coating 0766, Lot XXXX (exp. 11/01/2013); GEN 3784, Coating 0767, Lot XXXX (exp. 11/01/2013); and GEN 3785, Coating 0768, Lot XXXX (exp. 10/01/2013 and 11/01/2013). The term GEN and Coating refer to specific segments of the reagent lot number.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Disribution - USA Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
  • Descripción del producto
    VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, || Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

59 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lots #s: 0329-0528-8193 (exp. 05/01/2017), 0329-0528-8892 (exp. 06/01/2017), 0329-0528-8192 (exp. 05/01/2017), 0329-0528-8902 (exp. 06/01/2017), 0329-0528-8226 (exp. 05/01/2017), 0329-0528-8928 (exp. 07/01/2017),  0329-0528-8227 (exp. 05/01/2017), 0329-0528-9000 (exp. 07/01/2017), 0329-0528-8359 (exp. 05/01/2017), 0329-0528-8927 (exp. 07/01/2017), 0329-0528-8361 (exp. 05/01/2017), 0329-0528-8965 (exp. 07/01/2017), 0329-0528-8360 (exp. 05/01/2017), 0329-0528-8966 (exp. 07/01/2017),  0329-0528-8324 (exp. 05/01/2017), 0329-0528-9167 (exp. 07/01/2017), 0329-0528-8323 (exp. 05/01/2017), 0329-0528-9171 (exp. 07/01/2017), 0329-0528-8325 (exp. 05/01/2017), 0329-0528-9196 (exp. 07/01/2017), 0329-0528-6999 (exp. 03/01/2017), 0329-0528-9172 (exp. 07/01/2017), 0329-0528-7000 (exp. 03/01/2017), 0329-0528-9177 (exp. 07/01/2017), 0329-0528-6998 (exp. 03/01/2017), 0329-0528-9265 (exp. 07/01/2017), 0329-0528-8903 (exp. 06/01/2017), 0329-0528-9176 (exp. 07/01/2017), 0329-0528-8901 (exp. 06/01/2017), 0329-0528-9264 (exp. 07/01/2017), 0329-0528-8893 (exp. 06/01/2017), 0329-0528-9368 (exp. 07/01/2017), 0329-0528-8891 (exp. 06/01/2017), 0329-0528-9369 (exp. 07/01/2017).
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the countries of Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland and Venezuela.
  • Descripción del producto
    VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack || Product Usage: || For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).
  • Manufacturer
  • Modelo / Serial
    Lots 2915 (exp. December 2016) and 1995 (exp. July 2016)
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, and Venezuela.
  • Descripción del producto
    VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics || For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
  • Manufacturer
  • Modelo / Serial
    Product Code REF 680 0120 Lot: GENs 14-18  Expiry Date range 01-JAN-2017 through 01-MAY-2018
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - Nationwide U.S.A; International - Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
  • Descripción del producto
    VITROS Chemistry Products UPRO Slides, UPN 10758750000593, || Product Usage: || Quantitative measurement of total protein concentration in urine.
  • Manufacturer
  • Modelo / Serial
    Generation (GEN): 1 through 6, 30 through 40, 44 through 49 Expiry Dates: 01-JAN-2017 through 01-JUN-2018
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
  • Descripción del producto
    VITROS Na+ Slides, (UPN 10758750004812) || For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
  • Modelo / Serial
    Lot 91461, Expiry Date 2018-09-19; Affected Assay Data Diskettes (ADD) Release Versions 5904 through 5910
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide and, Puerto Rico) and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
  • Descripción del producto
    VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 --- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- Background: VITROS assays must be calibrated prior to use in order to be used to produce assay results. The Assay Data Disk (ADD) contains calibrator assigned values/ calculation data for multiple VITROS Calibrators and Lots. The Data Release Version (DRV) number identifies the version of the ADD. Each time the ADD is updated with new ata, the DRV number increments higher. The DRV with the highest number contains the most || current data. The VITROS 4600 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System are the only VITROS Systems that run the assays that are associated with VITROS Chemistry Products FS Calibrator || 1. VITROS FS Calibrator 1 is required to calibrate VITROS RF, dLDL, hsCRP, AMPH, BARB, BENZ, COCM, CP, ASO, THC, d%A1c assays. || VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. VITROS FS Calibrator 1 is used on VITROS Systems to calibrate the following assays: VITROS AMPH, ASO, BARB, BENZ, COCM, d%A1c, dLDL, hsCRP, PCP, RF and THC Reagents
  • Manufacturer
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