Gentian Cystatin C Calibrator Kit. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00992-1

Class II

2017-08-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00992-1

The manufacturer gentian has identified an issue with two specific lots of gentian cystatin c calibrator kit (lot 0006 and 0008). the identified lots of calibrators resulted in a high bias when used on a dxc instrument. potential risks associated with the increased bias are an underestimation of the cystatin c value, which again gives an overestimation of gfr. the bias should be detected when using controls for validation of the calibration curve. as a worst case in the event this is not detected by the controls, the bias may be close to 20%.

Beckman Coulter is requesting users: 1. Inspect their stocks and immediately stop using calibrator lots 0006 and 0008; 2. Share this information with laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, provide them a copy of this letter; 3. Complete and return the Response Form supplied with the Customer Letter within 10 days as confirmation of receipt of this important communication; and 4. If you have any questions regarding this notice, contact your local Beckman Coulter Representative.