Xpert BCR-ABL Monitor assay (used for monitoring patients being treated for chronic myelogenous leukaemia). An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2017-RN-00083-1

Class II

2017-01-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00083-1

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.

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.