Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-01482-1

Class II

2017-12-06

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01482-1

The certificate of analysis (coa) and the primary labels of the affected vials of m3636 were mislabelled with an incorrect protein concentration value of 292.7 mg/l, which is sixteen times higher than the correct concentration of 18.3 mg/l. to date, agilent has received only one customer complaint about this issue. the customer detected the issue prior to testing and immediately contacted agilent. no patient harm was reported, and the customer had informed that they were able to complete the patient’s diagnostic testing with minimal delay.M3636 will perform as expected. there is no change to the concentration itself, just the incorrect concentration stated on the vial label and the coa. the secondary label (box label) contains the correct concentration of 18.3 mg/l.

Agilent Technologies Australia is advising customers to discard any affected vials of Monoclonal Mouse Anti-Human CDX2, Clone Dak-CDX2, Code No. M3636 in accordance with the IFU. Agilent Technologies will arrange for replacement of product from affected customers. Agilent Technologies is advising users who may have run results at an altered dilution due to the larger protein concentration and without appropriate run controls to review results and re-run where required.