Events

Rappel de Device Recall VITROS Chemistry Products Specialty Diluent

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
    67883
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1519-2014
  • Date de mise en oeuvre de l'événement
    2014-03-26
  • Date de publication de l'événement
    2014-04-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126555
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    Ortho clinical diagnostics (ocd) confirmed the potential for lower than expected c-reactive protein (crp) results only to be generated when using vitros chemistry products specialty diluent (lot f3168) or vitros chemistry products fs diluent pack 3 (lot 01-3266). the vitros instructions for use states that if the if a c-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with vitros specialty diluent or a patient sample containing a low concentration of crp. an initial threefold dilution is recommended. internal testing determined that results using vitros crp slides have the potential for approximately 51% bias using a 3x dilution factor.
  • Action
    On 3/26/2014, Urgent Product Correction Notification Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s), discard the affected lots and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Replacement product will be sent for the product discarded. J&J; Foreign affiliate consignees were notified by e-mail informing them of the issue on 3/26/2014.

Device

Device Recall VITROS Chemistry Products Specialty Diluent
  • Modèle / numéro de série
    Lot F3168 (exp. 30 Sep 2014)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Description du dispositif
    VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
  • 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