Elecsys CMV IgM assay (04784618190) - Diluent Universal. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2015-RN-00120-1

Class II

2015-02-12

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00120-1

Internal investigation results by roche diagnostics confirmed that certain lots of diluent universal may have an influence on the cmv igm results and may lead to low or false negative results with two lots of the elecsys cmv igm assay. roche confirmed that a specific component used in the diluent universal caused the signal reduction of an internal control sample in the elecsys cmv igm assay. this internal control sample showed a high reactivity against one of the three specific antigens included in the cmv igm assay. the signal reduction has only minor effects on the calibrators and controls (precicontrol cmv igm) and therefore is likely to remain undetected, resulting in false non-reactive cmv igm results and undetected acute cmv infections. in summary, there is a reasonable probability that the use of affected diluent lots may lead to delayed or incorrect diagnosis and/or treatment of acute cmv infection.

Roche Diagnostics is requesting the customers to discard all current stocks of affected Diluent Universal and replace with the Diluent Universal (11732277122 - LOT 181121) that has been shipped to the laboratories free of charge. Roche Diagnostics is further requesting laboratories to review the Negative Elecsys CMV IgM patient samples tested between 1st November 2014 and receipt of this notice, whose results fell within the COI range of 0.5-0.7 COI and were obtained using one of the Diluent Universal lots and recommending appropriate patient re-testing with the new diluent lot provided. This action has been closed-out on 17/08/2016.