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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00063-1
Product Name/Description	Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD). Kit Item Number: CR2003 Lot Numbers: 161019161504NZ & 161007110553JG ARTG Number: 272537
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	12/01/2017
Responsible Entity	Abacus ALS Pty Ltd
Reason/Issue	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.
Recall Action	Recall
Recall Action Instructions	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.
Contact Information	1800 222 287 - Abacus ALS