The FDA warned healthcare providers and labs Aug. 17 of issues with Thermo Fisher Scientific's TaqPath COVID-19 test that may lead to false results.
The agency said it has found two issues related to both the test kit and the software used to run the test. The test was granted emergency authorization in March and is a nasal swab test.
The equipment issue could lead to false positives. The FDA said Thermo Fisher has updated instructions on certain steps of the test to resolve the issue.
The second issue requires labs to upgrade their software to reduce the risk of false negatives or inconclusive tests.
The FDA didn't say how many test results may have been affected by the issues.
Providers should review all positive results and consider them in combination with clinical observations, patient history and epidemiological information, the FDA said.
Read the full news release here.