Events

Recall of 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
    75526
  • Event Risk Class
    Class 2
  • Event Number
    Z-0408-2017
  • Event Initiated Date
    2016-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150711
  • 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
    Beckman coulter has determined that the access ostase calibrator and access ostase qc lots do not meet their expiration date claims within the 10% criteria.
  • Action
    Beckman Coulter sent an Urgent Medical Device Recall letter dated October 24, 2016 was sent to all their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions regarding the notice are instructed to contact Customer Technical Support Center at http://www.beckmancoulter.com, (800) 854-3633 in US and Canada, and to contact local Beckman Coulter representative if outside of US and Canada.

Device

Access Ostase QC
  • Model / Serial
    628297 623207 626001
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: UT, MI, MA, LA, IN, NC, CA, TX, NJ, IL, WI, MN, FL, KA, NY, CO, WA, KY, VA, and AL. Affected geographies: Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Philippines, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan.
  • Product Description
    Access Ostase QC, Catalog No. 37309, B83877 || Product Usage: || The Access Ostase QC is intended 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