Events

Rappel de MultiAnalyte Urine DAU Intermediate Calibrator

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 Lin-Zhi International 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
    60757
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0847-2012
  • Date de mise en oeuvre de l'événement
    2011-10-11
  • Date de publication de l'événement
    2012-01-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106403
  • 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
    Calibrators, drug mixture - Product Code DKB
  • Cause
    Catalog # 0804 multi-analyte urine dau intermediate calibrators were incorrectly labeled and mistakenly filled with catalog # 0805 dau high calibrators.
  • Action
    Lin -Zhi International sent a Recall letter dated October 11, 2011, and a e-mail to all affected customers. This was followed up by a personal phone call from Lin-Zhi personnel. The letter identified the product the problem and the action needed to be taken by the customer. The customer will be contacted to determine whether or not they were affected by this non-conformity. If they have been affected, they will be offered replacement Multi-Analyte Urine Intermediate Calibrators which are currently estimated to have a four week wait time before they become available. For further questions please call (408) 732-3856.

Device

MultiAnalyte Urine DAU Intermediate Calibrator
  • Modèle / numéro de série
    Catalog 0804; lot number 1101138K2, exp 1/28/2013
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of NC,MA, NH and TX. and the country of Germany,
  • Description du dispositif
    Multi-Analyte Urine DAU Calibrator (15 mL); || Multi-Analyte,Intermediate Calibrator; || for in-vitro diagnostic use only. || Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. || Drug abuse testing || Lin-Zhi International, Inc.' || 670 Almanor Ave. || Sunnyvale, CA 94085.
  • Manufacturer
    Lin-Zhi International Inc

Manufacturer

Lin-Zhi International Inc
  • Adresse du fabricant
    Lin-Zhi International Inc, 670 Almanor Ave, Sunnyvale CA 94085-3513
  • Société-mère du fabricant (2017)
    Lin-Zhi International Inc.
  • Source
    USFDA