The company issued the Class I recall in February because poor lamination between sample reaction wells led to inaccurate results, but has since resolved the issue.
The Australian firm provided an update on its in vitro diagnostics business, noting that it has also rebranded its core technologies and continues to license them.
Focus Diagnostics' Simplexa Direct test for herpes simplex viruses 1 & 2 was its first molecular test for the viruses and seventh overall to get FDA clearance.