Events

Recall of Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains Level 2). An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bio-Rad Laboratories 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-2018-RN-00495-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00495-1
  • 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
    Bio-rad have received multiple customer complaints indicating that some analyte values in certain vials of liquichek urine chemistry control level 2, lot 68512, are recovering outside the package insert stated ranges, namely high cvs.The performance of level 1, lot 68511 is not impacted.To date, there have been no reports of injury or illness as a result of this issue.
  • Action
    Bio-Rad is advising customers to inspect and quarantine affected units to prevent further use. Customers are advised to discard any remaining inventory of Liquichek Urine Chemistry Control, Level 2 Lot 68512 and MiniPak 395X Lot 68510 (that contains the level 2). Users are advised to contact Bio-Rad to make arrangements for replacement or to alter any pending orders or shipments. The replacement stock of Liquichek Urine Chemistry Control Level 2 is Lot 65822.

Device

Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains...
  • Model / Serial
    Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains Level 2). An in vitro diagnostic medical device (IVD)Liquichek Urine Chemistry Control Level 2Catalogue Number: 398Lot Number: 68512Expiry Date: 30 Sept 2019Liquichek Urine Chemistry Control MiniPak (contains Level 2)Catalogue Number: 395XLot Number: 68510Expiry Date: 30 Sept 2019ARTG Number: 206309(Bio-Rad Laboratories - Clinical chemistry biological screening IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd