Events

Rappel de PLAC Test Reagent Kit, immunoturbidimetric method

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 DiaDexus, Inc.

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
    53856
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1752-2010
  • Date de mise en oeuvre de l'événement
    2009-10-29
  • Date de publication de l'événement
    2010-06-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86706
  • 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
    Test, system, immunoassay, lipoprotein-associated phospholipase a2 - Product Code NOE
  • Cause
    Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.
  • Action
    Notification letter issued to consignees on 10/29/2009. Customers were instructed to not report PLAC test results for samples that are greater than 360 ng/mL, and pursue confirmatory testing by contacting DiaDexus. Customers with questions please call the company technical support line toll free at 1-877-752-2837 for assistance. UPDATE: On April 30, the firm suspended marketing of the PLAC TIA method, as the limited range no longer covered the clinical data/reference range data cited in the product insert. The firm sent out a letter notifying customers on May 10, 2010. The firm set up a sample send out program, so that customers can send samples to labs running the ELISA method PLAC test. Arrangements were made so that labs could be enabled to run a CLIA complex assay, for customer credit programs for un-used products, and a fax back response form for response tracking.

Device

PLAC Test Reagent Kit, immunoturbidimetric method
  • Modèle / numéro de série
    Lot numbers 078011, 088061, 098091, 109011, 119021, 129031, 139051, 139051A
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to 123 consignees throughout the US.
  • Description du dispositif
    PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA.
  • Manufacturer
    DiaDexus, Inc

Manufacturer

DiaDexus, Inc
  • Adresse du fabricant
    DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080
  • Société-mère du fabricant (2017)
    DiaDexus, Inc
  • Source
    USFDA