Events

Recall of Epiclone Anti N BGR - Immunohaematology Reagent. 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 Seqirus 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-00754-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00754-1
  • 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
    Seqirus received a report from a customer that lot 009934602 presented false positive results during pre-acceptance testing (cells known to be n negative phenotype presented positive results during tube testing). this was subsequently confirmed to have occurred for multiple customers.Additional customer feedback was also received for a separate epiclone anti n lot (009934501) where the customer reported the product to be “uncharacteristically sticky”, causing red cells to adhere to the inner surfaces of the tube (tube testing technique), resulting in difficulty to confirm whether the reaction produced a positive or negative result.Following these customer reports, investigational testing on all epiclone lots within expiry was performed, which confirmed that epiclone anti n lots 009934401, 009934501, 009934602 and 009934701 are capable of presenting false positive results against certain n negative samples.
  • Action
    1.Quarantine all affected units from further use. 2. Package all quarantined units and label “For Drug Recall Attention (Authorised Recall Officer)” 3. Mark on the outside of each package the name of the organisation or institution returning the product. 4. Complete the Facsimile/Email Reply Form supplied with the customer letter and fax/email back to Seqirus Customer Service so that they may arrange for affected stock to be recovered, including if no product is in stock. 5. Seqirus will provide replacement of returned stock once alternative product is available. 6. Review previous results generated with the affected lot numbers as required.

Device

Epiclone Anti N BGR - Immunohaematology Reagent. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Epiclone Anti N BGR - Immunohaematology Reagent. An in vitro diagnostic medical device (IVD).Item Code: 00990501Lot Numbers: 009934401, 009934501, 009934602 and 009934701ARTG Number: 225013
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd