Detect’s COVID-19 test recalled due to risk of false-negative results

Detect Inc. is voluntarily recalling 11,102 COVID-19 tests. This is because the recalled tests are more likely to give false-negative results. Food and Drug Administration announced Monday.

The company’s recall, which began Thursday, covers three lot numbers: HB264, HY264 and HY263. The largest percentage of lots recalled – 7,382 tests – was HB264, with 1,800 of his HY263 shipped and 1,920 of his HY264.

The recall will affect “tests shipped to customers between July 26, 2022 and August 26, 2022,” according to the FDA’s announcement. The expiry date for all recalled tests is his January 1st.

Detect’s voluntary recall was done out of caution, but neither the company nor the FDA elaborated on why the test raised concerns.

“To date, Detect has not received reports of false negative results related to affected lots,” the FDA notice said.

Positive test results for recalled tests are still valid.

Detect will notify the customer who purchased the recalled test and provide a refund as long as the customer acknowledges receipt of the recall notice and confirms that the recalled test they purchased has been destroyed.

Unused tests should be discarded. “All test components can be disposed of as normal waste, but the outer packaging is recyclable.”

Detect Inc.’s testing comes with a Detect hub that handles testing and a Detect app that guides users through the testing process for COVID-19.