Events

Recall of Xpert BCR-ABL Monitor assay (used for monitoring patients being treated for chronic myelogenous leukaemia). 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 Cepheid Holdings 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-00083-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00083-1
  • 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
    Internal tests conducted by cepheid show that certain lots of xpert bcr-abl monitor (bcr-100n-10) meet performance claims up to 12 months after the date of manufacture instead of the current expiration dating (up to 24 months). assay stability data beyond 13 months under reported the amount of bcr-abl mrna transcript at the lowest level. the claimed performance for the assay allows for a 2-fold variance in the ratio of bcr-abl to abl mrna transcripts whereas at 25 months a 3-fold difference was observed. at 13 months a 1.8-fold variance was observed, which is within the claimed product performance variability. although outside of the stability limits, the detected level of bcr-abl mrna transcript is correctly called as bcr-abl detected.The expiry dates of affected lots have changed to reflect the new 12 month timeframe. as a result, lot 1000026629 expired as of 4 jan 2017, and lot 1000027258 and 1000040993 will expire in march 2017 and august 2017, respectively.
  • Action
    Cepheid is advising, based on the assignment of the new expiry date, that Xpert BCR-ABL Lot 1000026629 (Cartridge Lot 21503) expired on 4 Jan 2017. Customers are to stop using and dispose of product from this lot. Cepheid will provide replacement product. Results obtained using this lot from tests run after 4 Jan 2017 should be reviewed for outliers not associated with known clinical factors (eg. therapy compliance). For Lot 1000027258 (Cartridge Lot: 21703) and Lot 1000040993 (Cartridge Lot: 22402), the new expiry dates are 1 Mar 2017 and 15 Aug 2017, respectively. Customers are to stop using and dispose of remaining product from these lots after the newly assigned expiry dates. Cepheid will provide replacements for product remaining after the new expiry dates. This action has been closed-out on 28/02/2018.

Device

Xpert BCR-ABL Monitor assay (used for monitoring patients being treated for chronic myelogenous l...
  • Model / Serial
    Xpert BCR-ABL Monitor assay (used for monitoring patients being treated for chronic myelogenous leukaemia). An in vitro diagnostic medical device (IVD).Catalogue Number: BCR-100N-10Lot Number: 1000026629 (Cartridge Lot: 21503)Expiry on label: 9 Apr 2017Lot Number: 1000027258 (Cartridge Lot: 21703)Expiry on label: 9 Apr 2017Lot Number: 1000040993 (Cartridge Lot: 22402)Expiry on label: 25 Feb 2017ARTG Number: 226631
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd