Events

Rappel de Device Recall Piccolo Comprehensive Metabolic Panel

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 Abaxis, Incorporated.

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
    57321
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1066-2011
  • Date de mise en oeuvre de l'événement
    2010-11-19
  • Date de publication de l'événement
    2011-02-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95843
  • 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
    Nadh oxidation/nad reduction, alt/sgpt - Product Code CKA
  • Cause
    Abaxis has determined that during the manufacture of product lot 0396bc5 may report inaccurate values of alanine aminotransferase (alt) when used in the piccolo blood chemistry analyzer or piccolo xpress chemistry analyzer.
  • Action
    The firm, Abaxis Inc., sent an "URGENT PRODUCT RECALL NOTICE" dated November 19, 2010, to all customers. The notice described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory of the lot for boxes #0665 or higher; if found, to discontinue use; contact Abaxis for immediate replacement; complete and return the enclosed PRODUCT RECALL RESPONSE form to Abaxis Technical Support via fax at 1-877-349-2087, and ensure that their laboratory staff is informed of this recall notice. If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, or at medtechsupport@abaxis.com.

Device

Device Recall Piccolo Comprehensive Metabolic Panel
  • Modèle / numéro de série
    Lot Number: 0396BC5  Boxes # 686 - 834 and # 665-685.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries of: Kowloon and Germany.
  • Description du dispositif
    Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; || Product is manufactured and distributed by Abaxis, Incorporated, || Union City, CA || The Piccolo Comprehensive Metabolic Reagent Disc, used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma or serum. The patented self¿contained reagent rotors are bar coded, contain liquid diluents and dry reagents and use centrifugal and capillary technology to provide the most commonly requested chemistry panel results in approximately 12 minutes. The Piccolo Comprehensive Metabolic Panel, used with the Piccolo Blood Chemistry Analyzer is a diagnostic system that aids in disease diagnosis or monitoring disease treatment.
  • Manufacturer
    Abaxis, Incorporated

Manufacturer

Abaxis, Incorporated
  • Adresse du fabricant
    Abaxis, Incorporated, 3240 Whipple Rd, Union City CA 94587
  • Société-mère du fabricant (2017)
    Abaxis Inc
  • Source
    USFDA