Events

Rappel de Device Recall VITROS Immunodiagnostic Products AFP Reagent Pack

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
    74346
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2145-2016
  • Date de mise en oeuvre de l'événement
    2016-05-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147248
  • 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
    Kit, test,alpha-fetoprotein for testicular cancer - Product Code LOJ
  • Cause
    Ortho clinical diagnostics (ocd) confirmed that specific lots of vitros immunodiagnostic products afp reagent pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.
  • Action
    The firm, Ortho Clinical Diagnostics, sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Customer Letter (Ref. CL2016-098) dated 5/9/2016, 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 product. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue distributing and discard the affected lots; complete and return the Confirmation of Receipt form by May 18, 2016 via Fax to 1.888.557.3759 or 1.585.453.4110 or scan to PDF and email to: ConfirmationAdmin@its.jnj.com, and forward this notification if you have distributed these systems outside of your facility. If you have any questions, contact Customer Technical Services at 1-800-421-3311.

Device

Device Recall VITROS Immunodiagnostic Products AFP Reagent Pack
  • Modèle / numéro de série
    Lots 6471 (expiry date 19-Jul-2016), 6480 (expiry date 23-Aug-2016)
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. || For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS
  • Adresse du fabricant
    ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS, Bridgend United Kingdom
  • Société-mère du fabricant (2017)
    The Carlyle Group LP
  • Source
    USFDA