Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2017-RN-00063-1

Class II

2017-01-12

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00063-1

Some lots of the crag lfa have been found to have reduced specificity (90% now versus 99% before). the health risk only applies to patients with positive test results. a small number of samples with positive test results may not be true positives, which may cause some patients to initiate unnecessary anti-fungal therapy. samples with negative test results are not affected. the negative predictive value remains high at nearly 100%. there have been two customer complaints associated with this problem. there have been no reports of patient injury or death.

Abacus ALS is advising users to destroy stock from the affected lots to prevent further use. Replacement stock will be provided. Customers may decide to retest samples previously reported as positive using affected lots. Abacus ALS will provide replacement tests to perform retesting if this is required. This action has been closed-out on 01/03/2018.