Events

Recall of Device Recall Vidiera NsP Nucleic Sample Preparation

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
    48660
  • Event Risk Class
    Class 2
  • Event Number
    Z-0454-2009
  • Event Initiated Date
    2007-08-30
  • Event Date Posted
    2008-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71828
  • 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
    Pipetting and diluting system for clinical use. - Product Code JQW
  • Reason
    Incorrect results: under certain circumstances, when transfer volume is not within the set range, the vidiera nsp software does not report sample exclusion and does not flag the excluded sample in the "run results" report. the software error associated with the excluded sample appears as "liquid was not successfully transferred to well#..........The sample will be excluded from further proce.
  • Action
    The customer notifications were initiated by Beckman Coulter on September 11, 2007 when all affected accounts were contacted via telephone, followed by a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers of the issue and instructed them to: (1) Review the "run Summary" event log for your samples. (2) Review the attached instructions describing the steps for identifying the samples affected by this error. (3) Complete and return the enclosed response form within 10 days so that we may maintain our records. The letter informed the customers that Beckman Coulter would provide a software update within 60 days. The letter also asked their customers to share the PCA with their staff and provide a copy of the PCA to any customers that they may have forwarded the affected products to. For questions regarding the PCA, please contact firm at 714-961-3634.

Device

Device Recall Vidiera NsP Nucleic Sample Preparation
  • Model / Serial
    Part Numbers: A22421, Version 1.0.41
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution including states of PA, MI, UT, WA, IL, and CA.
  • Product Description
    Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA