Events

Recall of COULTER PREPPLUS 2

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    28456
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-31
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Beckman coulter is updating the prepplus operator's guide (pn 4237638da) and prepplus 2 instructions for use manual (pn 4277264ba) to modify the list of validated specimen tubes for use on the systems. we have determined that the specimen tubes being removed from the specimen tube list may not meet the "dead volume" (i.E. the amount of specimen that the system cannot access at the bottom of the tube) claim. if a specimen tube does not have sufficient dead volume the preparation of the specimen will not be compromised because the user will be alerted to the error through one or more error messages as indicated in the product labelling.

Device

COULTER PREPPLUS 2
  • Model / Serial
    Model Catalog: 378600 (Lot serial: >10 numbers contact mfg.); Model Catalog: 286600 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    COULTER PrepPlus 2
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.