Events

Rappel de Device Recall VITROS Chemistry Products Li Slides

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ortho-Clinical Diagnostics.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    76438
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1471-2017
  • Date de mise en oeuvre de l'événement
    2017-02-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153213
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Flame photometry, lithium - Product Code JIH
  • Cause
    Intermittent imprecision in results generated using two specific lots of vitros li slides.
  • Action
    On 2/01/ 2017, URGENT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2017-036, dated 2/01/2017) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected VITROS Chemistry Products Li Slides to inform them of the issue and to request that they immediately discontinue use of this product. The correction is to the user level. Discuss any concerns regarding previously reported VITROS Li results obtained from the affected with their Laboratory's Medical Director to determine the appropriate course of action. Ortho will be shipping replacement product. ---Foreign affiliates were informed of the issue by e-mail on 2/01/2017 and instructed to notify their consignees of the affected product with this issue and the requirement to immediately discontinue use of the product. For questions, please contact our Ortho Care(TM) Technical Solutions Center at 1-800-421-3311.

Device

Device Recall VITROS Chemistry Products Li Slides
  • Modèle / numéro de série
    REF/Product Code 1632660: Lot 3124-0108-6568, exp. 2018- 04-01; REF/Product Code 8318925: Lot 3124-0108-6569, exp. 2018- 05-01
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic.
  • Description du dispositif
    VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 --- Background: || The VITROS Li Slide is a multilayered, analytical element coated on a polyester support. During the coating process, thin layers of reagents are coated onto a polyester support layer to create a spreading layer and a chemical (reagent) layer. During the coating process rolls of materials are produced. These rolls are segmented into slits. There are several slits in each roll. Each slit is then cut into small chemistry chips that are positioned between plastic to create the final Microslide format. Eighteen (18) or sixty (60) slides are placed into each plastic cartridge for use. Each slide is a device.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Société-mère du fabricant (2017)
    The Carlyle Group LP
  • Source
    USFDA