Detect Inc. is voluntarily recalling 11,102 of its COVID-19 tests due to increased chances of the recalled tests producing a false negative result, the Food and Drug Administration announced Monday.
The company’s recall, which it began Thursday, targets three lot numbers, HB264, HY264 and HY263. The largest share of the recalled lots — 7,382 tests — were HB264s, versus 1,800 HY263 tests and 1,920 HY264 tests having been shipped.
The recall affects “tests shipped to customers from July 26th, 2022 through August 26th, 2022,” according to the FDA announcement. All the recalled tests have a use-by date of Jan. 1.
The voluntary recall by Detect was done from an abundance of caution, though neither the company nor the FDA elaborated on what had given them fears about the tests.
“To date, Detect has not received any reports of false negative results related to the affected lots,” the FDA notice stated.
Positive test results from the recalled tests are still valid.
Detect is notifying customers who purchased the recalled tests, offering refunds so long as the customers acknowledge receiving the recall notice and can confirm the recalled test they purchased was discarded.
Unused tests should be discarded, Detect urged, noting that “the outer packaging is recyclable while all the test components can be discarded as regular trash.”
The Detect Inc. tests are accompanied by the Detect Hub that processes the tests and a Detect app that guides users through the COVID-19 testing process.
Those who attempt to use recalled tests will be notified in the Detect app that the tests can no longer be used. The Detect Hub, the company wrote, was not subject to the recall.