Events

Recall of AcroMetrix PeliSpy Sero Control Type 36 and Type 38. 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 Life Technologies 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-2013-RN-00084-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00084-2
  • 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
    The manufacturer of pelispy sero control type 36 and type 38 advises that affected lots may produce signal to cut-off (s/co) ratios <1 when run on the prism hbsag assay. consequently, if these lots are implemented as a go-no-go control using a threshold s/co ratio of 1 in the prism hbsag assay, test runs may need to be failed.
  • Action
    Life Technologies is requesting users to inspect and quarantine any affected lots. Arrangements for stock recovery and replacement will be arranged upon confirmation of affected units.

Device

AcroMetrix PeliSpy Sero Control Type 36 and Type 38. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    AcroMetrix PeliSpy Sero Control Type 36 and Type 38. An in vitro diagnostic medical device (IVD)Type 36Catalogue number: 964608 and S2381Lot numbers: 201305 (Expiry date: 01/2014) and 035717 (Expiry date: 03/2013) Type 38Catalogue number : 964609 and S2404Lot numbers : 035716 (Expiry date: 01/2014) and 220905 (Expiry date: 08/2014)ARTG Number: 192532
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd