Events

Rappel de Device Recall IRISpec" CA/CB twopart urine chemistry control twin set

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 Iris 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
    62555
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2124-2012
  • Date de mise en oeuvre de l'événement
    2012-07-09
  • Date de publication de l'événement
    2012-08-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110976
  • 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
    Urinalysis controls (assayed and unassayed) - Product Code JJW
  • Cause
    The firm recalled after it received complaints of irispec ca/cb two part urine chemistry control, 101131-12, where the nitrite results read negative for the part b control, which should be positive.
  • Action
    The firm initiated the recall on 07/09/12 by sending out a Medical Device Recall notification to customers via e-mail. The recall notification identified the affected product, reason for recall, and instructions on the recall. Customers were to confirm how many sets of unopened or partially opened IRISpec CA/CB that was in their inventory, dispose of the affected product, and provide written confirmation of the product's disposition. The letter also stated that Iris Diagnostics would replace any unused inventory that was returned at no charge to the customer. Contact information for the recall was also provided. The communications also included a fax response sheet for return/replacement.

Device

Device Recall IRISpec" CA/CB twopart urine chemistry control twin set
  • Modèle / numéro de série
    Iris Diagnostics part number 800-0074, lot number 131-12.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. || Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
  • Manufacturer
    Iris Diagnostics

Manufacturer

Iris Diagnostics
  • Adresse du fabricant
    Iris Diagnostics, 9172 Eton Ave, Chatsworth CA 91311-5805
  • Source
    USFDA