Events

Rappel de Tosoh Folate calibrator sets

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 Tosoh Bioscience 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
    36506
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0082-2007
  • Date de mise en oeuvre de l'événement
    2006-09-01
  • Date de publication de l'événement
    2006-10-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-07-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48775
  • 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
    Folate calibrator sets - Product Code JIS
  • Cause
    Reports of low calibration rate value flags; use of the recalled product may result in failure to calibrate the instrument.
  • Action
    The firm mailed Urgent: Medical Device Recall letters to their customer accounts on 9/5/2006. The letter informs the customers of the calibration problem and asks that the customers examine their inventories for the presence of the suspect product and place any product found in quarantine. The letter also asks that the customers identify their subaccount/customers and notify them of the recall with a copy of the recall letter, if the product has been further distributed. The recall letter is accompanied by a Response form which the customer is asked to complete and return to TOSOH as soon as possible. The Response form requires reporting of infomation concerning the amount and disposition of all product on-hand. It also includes a section for use by the distributor/customers for indicating whether or not their customers have been notified as well as the names and addressed of the distributor''s subaccounts. Should the customer(s) have any questions, the recall letter provides a telephone number and the name of a contact person to whom questions can be addressed.

Device

Tosoh Folate calibrator sets
  • Modèle / numéro de série
    Lot Code: G431726 (shipped after June 6, 2006)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution ---- including states of AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TX, WA, WI, WV, and WY.
  • Description du dispositif
    TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box.
  • Manufacturer
    Tosoh Bioscience Inc

Manufacturer

Tosoh Bioscience Inc
  • Adresse du fabricant
    Tosoh Bioscience Inc, 3600 Gantz Road, Grove City OH 43123
  • Source
    USFDA