Events

Rappel de Device Recall Access Ostase Calibrators

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 Beckman Coulter 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
    58833
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2605-2011
  • Date de mise en oeuvre de l'événement
    2011-05-10
  • Date de publication de l'événement
    2011-06-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100389
  • 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
    Calibrator primary - Product Code JIS
  • Cause
    The recall was initiated because beckman coulter has confirmed that access ostase calibrator and qc vials from the affected lots have shown an increased rate of fracturing and may leak the contents in the box during shipment to customers. operator injury may occur due to contact with broken glass, exposure to infectious agents, and/or exposure by skin contact to agents that may cause sensitizatio.
  • Action
    Beckman Coulter sent an PRODUCT CORRECTIVE ACTION (PCA) letter on May 10, 2011 to all affected customers who purchased Access Ostase Calibrators and Access Ostase QC. The letter identified the customers with an explanation of the problem and the potential impact should the problem occur and the action needed to be taken. Customer were instructed to: (1) Inspect all Access Ostase Calibrator and QC vials and packaging for signs of failure prior to use, including: -Cracking, particularly along the bottom of the vial, -Absence of reagent and/or leaking of contents into the box (2) Human source material used in the preparation of Access Ostase Calibrator and QC material has been tested and found non-reactive for Hepatitis B (HBV), Hepatitis C (HCV), and Human Immunodeficiency Virus (HIV-1 and HIV-2). No known test method can offer complete assurance that infectious agents are absent. Access Ostase Calibrator and QC vials should be handled in accordance with Good Laboratory Practices, and should be handled as if capable of transmitting infectious disease. (3) Skin contact with Access Ostase Calibrator and QC material may cause sensitization. Wear suitable gloves when handling vials. If contact with skin occurs, wash immediately with plenty of soap and water. Customers were told to share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide a copy of the letter to them. In addition, customers were requested to complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. For replacement of defective vials: (1) In the United States, please contact Client Services at 1-800-526-3821, option 1. (2) In Canada, please contact Customer Service at 1-800-463-7828. (3) Outside of the United States and Canada, contac

Device

Device Recall Access Ostase Calibrators
  • Modèle / numéro de série
    Lot Numbers:  013490, 015210, 018854, 020419, 022834, 109632
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in US and worldwide to: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, New Zealand, Panama, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom
  • Description du dispositif
    Access Immunoassay Systems || Ostase Calibrators, Part Number: 37305 || The Access Ostase Calibrators are used to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA