Events

Recall of SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.

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
    35258
  • Event Risk Class
    Class 2
  • Event Number
    Z-0886-06
  • Event Initiated Date
    2006-03-30
  • Event Date Posted
    2006-05-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45675
  • 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
    Radioimmunoassay, Vancomycin - Product Code LEH
  • Reason
    Beckman coulter has received reports of patient samples and quality control recovery shifting low when using vancomycin reagent lots m507219 and m511327. internal qc recovery was as much as 15% lower than the assigned target value.
  • Action
    A Product Corrective Action (PCA) letter was be sent the week of MAR 30, 2006 to all SYNCHRON Systems Vancomycin Reagent customers of lot numbers M507219 and M511327 informing them to discontinue use and discard reagent. (Letters were sent by US mail)

Device

SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.

Manufacturer

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