Events

Rappel de Device Recall Toxoplasma IgM ELISA 96 Well Kit

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 Calbiotech 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
    50691
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1002-2012
  • Date de mise en oeuvre de l'événement
    2008-08-27
  • Date de publication de l'événement
    2010-03-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-03-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76382
  • 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
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii - Product Code LGD
  • Cause
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Action
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.

Device

Device Recall Toxoplasma IgM ELISA 96 Well Kit
  • Modèle / numéro de série
    Lot Number: TXM2507
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    FL, and VA
  • Description du dispositif
    Toxoplasma IgM ELISA 96 Well Kit, Catalog Number: TX055M || The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
  • Manufacturer
    Calbiotech Inc

Manufacturer

Calbiotech Inc
  • Adresse du fabricant
    Calbiotech Inc, 10461 Austin Dr Ste G, Spring Valley CA 91978-1524
  • Source
    USFDA