Events

Rappel de iChemVELOCITY Urine Chemistry Strips

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Beckman Coulter Australia Pty Ltd.

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
    RC-2017-RN-01422-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-16
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01422-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Iris international has become aware of a strip manufacturing error where an incorrect pad was inadvertently placed in the location of the compensation pad. all the other analytes are correct. this defect exists on a subset of vials belonging to lot 7204170 a with the serial numbers of the impacted vials ranging from 10500 through 12818. beckman coulter is working on a resolution to prevent recurrence of this issue. this action is being taken following consultation with the therapeutic goods administration.
  • Action
    1. Inspect any remaining inventory to determine if you have the impacted vials The vial serial number is located on the bottom of the vial beneath the lot number. 2. Discard any remaining impacted vials. 3. Contact your local support representative for product replacement. 4. Consult with your Laboratory Director to determine if a retrospective review of results is clinically warranted. 5. Share this information with your laboratory staff and retain this notification. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. 6. Complete and return the supplied Response Form within 10 days so Beckman Coutler can be assured you have received this communication.

Device

iChemVELOCITY Urine Chemistry Strips
  • Modèle / numéro de série
    iChemVELOCITY Urine Chemistry StripsLot number: 7204170 ASerial Nunber: 10500 through 12818ARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd