Events

Recall of Monolisa HCV Ag-Ab ULTRA V2 assay. 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-2017-RN-00444-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00444-1
  • 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 laboratories have noticed a decrease of all optical densities (od) values for tested samples and controls. this could result in plate invalidation. specific lots are affected by this phenomenon which causes a global decrease of all od values appears some months after the manufacturing release of the lots. the reconstituted antigen positive control - r5 is more impacted by the decrease of od values and results in run invalidation when its od becomes lower than 0.5. however, since final results (ratios) are not impacted, there is no risk of an erroneous result.
  • Action
    Users are asked to; · To continue to use kits and lots in table 1 as long as the validation criteria are met (refer to product package insert (section 7.5) for detailed instructions): 1) For the negative control R3: O.D. < cut off x 0.6 2) For the antibodies positive control R4: 0.800 = Mean O.D. = 2.700 3) For the working solution R5: O.D. > 0.500 · To stop using kits of lots in table 1 if validation criteria failed. In that case, discard the kit, fill the Annex 1 Customer Response Form and return it to your customer service to obtain replacement kits.

Device

Monolisa HCV Ag-Ab ULTRA V2 assay. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Monolisa HCV Ag-Ab ULTRA V2 assay. An in vitro diagnostic medical device (IVD)1 plate - 96 testsCode Number: 72561Lot Numbers: 6J0029 (Expiry 15 Feb 2018), 6K0030 (Expiry 28 Feb 2018), 6K0031 (Expiry 15 March 2018), 6M0032(Expiry 15 April 2018), 7A0033 (Expiry 30 May 2018) 5 plates - 480 testsCode Number: 72562Lot Numbers: 6J0533 (Expiry 15 Feb 2018), 6K0534 (Expiry 28 Feb 2018), 6K0535 (Expiry 15 March 2018), 6M0536 (Expiry 15 April 2018)ARTG Number: 231015
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd