Events

Recall of Device Recall Access Ostase QC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58833
  • Event Risk Class
    Class 2
  • Event Number
    Z-2606-2011
  • Event Initiated Date
    2011-05-10
  • Event Date Posted
    2011-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100390
  • Notes / Alerts
    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.
  • Extra notes in the data
    Single (specified) analyte controls ( assayed and unassayed) - Product Code JJX
  • Reason
    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 QC
  • Model / Serial
    Lot Numbers:  911585, 015211, 018855, 020420, 021285, 021640
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    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
  • Product Description
    Access Immunoassay Systems || Quality Control Kits, Part Number: 37309 || The Access Ostase QC is used for monitoring system performance of the Access Ostase assay.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA