Events

Recall of Quantum Blue Calprotectin Assay and Quantum Blue Calprotectin High Range

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Taylor Bio-Medical 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-2016-RN-01270-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01270-1
  • 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
    A typographical error has been identified in certain quantum blue calprotectin assay kits. the printed expiration date on the labelling of the kits is incorrect. the correct expiry date is 2016-dec-31. there is no risk to health if the assay kits are used by this date.
  • Action
    Taylor Biomedical has advised customers to check if they have affected stock. Customers will be requested to include in the affected stock, an advisory notice with details of the correct expiry date. This action has been closed-out on 28/11/2016.

Device

Quantum Blue Calprotectin Assay and Quantum Blue Calprotectin High Range
  • Model / Serial
    Quantum Blue Calprotectin Assay and Quantum Blue Calprotectin High RangeQuantum Blue Calprotectin AssayLot Numbers: 2930N Expiry: 2017-July-31Quantum Blue Calprotectin High RangeLot Number: 2930N.HR Expiry: 2017-April-30
  • Manufacturer
    Taylor Bio-Medical Pty Ltd

Manufacturer

Taylor Bio-Medical Pty Ltd