Events

Rappel de Device Recall DSL108000 Active IPTH ELISA

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 Beckman Coulter 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
    55195
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0107-2011
  • Date de mise en oeuvre de l'événement
    2010-03-04
  • Date de publication de l'événement
    2010-10-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90278
  • 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
    Radioimmunoassay, parathyroid hormone - Product Code CEW
  • Cause
    The recall was initiated after beckman coulter confirmed that the stated stability of the dsl-10-8000 i-pth elisa assay may not be achieved for lot numbers: 891198, 990980 and 991448. the kit lot numbers listed above passed the stability testing performed at 6 months, but failed the testing performed at 12 months. therefore the affected i-pth elisa kit lots may produce falsely elevated patient r.
  • Action
    Beckman Coulter sent an URGENT: PRODUCT CORRECTIVE ACTION letter dated March 17, 2010 with attached Customer Response form to all customers who received Active I-PTH ELISA kits with the affected lot numbers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to: (1) Discontinue use of all materials provided with I-PTH ELISA kit lot numbers 891198, 990980 and 991448; (2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if your laboratory uses only the control materials provided with the I-PTH ELISA kit; (3) Abnormally elevated patient results that are obtained with these lot numbers and that are inconsistent with the patient's clinical status should be reviewed in the context of other clinical diagnostic tests; (4) I-PTH ELISA kit lot numbers 891198, 990980 and 991448 will no longer be shipped. Alternate lots will be provided for current and future replenishment orders or requests. in addition customers were instructed to share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. Complete and return the enclosed response form within 10 days. For questions regarding this recall contact (800) 231-7970.

Device

Device Recall DSL108000 Active IPTH ELISA
  • Modèle / numéro de série
    Lot Numbers: 891198, 990980, 991448
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of CA, CT, IA, IL, MI, NY, SC, and TX
  • Description du dispositif
    Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 || The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA