The agency said March 12 that the false positive results may be related to two issues:
- Assay tubes may sporadically leak
- Abnormal PCR cycling in reaction tubes
False positive test results could lead to improper patient management as well as unnecessary isolation and additional health monitoring, the FDA said. It may also lead to delayed diagnosis and treatment, and misallocation of resources.
The FDA said providers should monitor tests for unexpected clusters of positive flu results, which may indicate that the testing system has experienced a tube leak. The agency also advised to stop using the test and contact Roche if providers suspect either of the two issues has occurred.
The FDA said it’s working with Roche to resolve the issues. It didn’t say if it’s received any adverse event reports.
Read the FDA’s full news release here.
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