Events

Recall of Synchron Systems Microalbumin (MA) Reagent

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-00627-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00627-1
  • 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
    Beckman coulter has confirmed that ma reagent lot m609458 may recover outside the lower limit of the published insert range for beckman coulter urine protein control level 1. internal testing has confirmed that ma is recovering within the published insert range for beckman coulter urine protein control level 2.As a result, patient results with ma reagent lot m609458 may be up to 0.5 mg/dl lower than actual values. in addition, lower recovery of ma in urine protein control level 1 may cause ma to exceed the lower limits of a laboratory's established qc range.
  • Action
    Beckman Coulter is advising users to discontinue use and discard MA Reagent Lot M609458 following their laboratory's disposal protocol. Replacement product will be provided.

Device

Synchron Systems Microalbumin (MA) Reagent
  • Model / Serial
    Synchron Systems Microalbumin (MA) Reagent Reference Number: 475100Lot Number: M609458Expiry Date: 30 Sep 2018ARTG Number: 213984
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd