Events

Rappel de Device Recall MultiAnalyte Urine DAU Cutoff 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
    60743
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0868-2012
  • Date de mise en oeuvre de l'événement
    2011-08-23
  • 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=106374
  • 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
    Multi analyte urine dau cutoff calibrator gives a decreased absorbance reading due to a loss of the bzo (oxazepam) analyte from the solution and may cause false positive readings.
  • Action
    The firm, Lin-Zhi International, Inc., sent a notice by email dated August 23, 2011 to all customers. The notice described the product, problem and actions to be taken. Lin-Zhi will contact the customers to determine whether they want replacement BZO calibrators and controls immediately or if they are willing to wait a minimum of four weeks for a new lot of the Multi-Analyte Urine Cutoff Calibrators. The customers were instructed to contact Lin-Zhi with their replacement request. The notice also stated that the Lin-Zhi has plans to create more stringent QC standards and further R&D; regarding stabilization of this analyte in solution in its calibrators of controls containing BZO. If you have any questions or concerns regarding how this situation is being handled or the outcome, contact Lin-Zhi at (408)732-3856; email: customerservice@lin-zih.com or webpage: www.lin-zhi.com.

Device

Device Recall MultiAnalyte Urine DAU Cutoff Calibrator
  • Modèle / numéro de série
    Catalog number 0803; Lot 1101136K3, exp 1/28/13
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, FL, GA, IN, NC, NH, and TX; and country of: Germany.
  • Description du dispositif
    Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) || For in vitro diagnostic use only. || Lin-Zhi International, Inc.. || 670 Almanor Ave. || Sunnyvale, CA 94085 || intended use: Drug abuse detection.
  • 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