Events

Recall of DuraClone B27 Reagent Kit - an in vitro medical device

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

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
    RC-2017-RN-01514-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01514-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    As a result of internal investigations, beckman coulter has determined that certain duraclone b27 reagent kits have a defect that may generate false negative results in some samples. this defect is most likely to affect samples with mfi values between 10 to 19 when tested on navios/cytomics fc 500 cytometers and channel values between 517 to 602 when tested on bd facscalibur/ bc facscan cytometers.There has been no report of death or injury related to this defect.
  • Action
    Beckman Coulter is advising users to run tests of lot numbers 050917, 070417_11, 090517, 120617_02, 170417_09, 170417_11, 170417_11, 190617 and 240717 with the new determinant and indeterminant zone values provided with the Customer Letter. Other affected lot numbers should be disposed of in an appropriate manner. Affected customers may contact their local Beckman Coulter representative for replacement product. Beckman Coulter recommends if required, redetermination of those results obtained for the above specified 8 lot numbers using the new determinant values outlined in the Customer Letter. For all lot numbers, Beckman Coulter recommend samples previously reported as ‘negative’ to be verified using alternate methods such as PCR if considered necessary.

Device

DuraClone B27 Reagent Kit - an in vitro medical device
  • Model / Serial
    DuraClone B27 Reagent Kit - an in vitro medical deviceRef Number: B36862Multiple Lot Numbers AffectedARTG 224373
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd