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Safety Report: Detect, Inc. Over the counter Covid-19 Test - recalled due to may give false negative results, USA

1 year ago •source fda.gov

Recall notice

Detect, Inc. Over the counter Covid-19 Test - recalled due to may give false negative results photo #1

United States

Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, their molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 through August 26th, 2022. The test was granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on October 28, 2021. To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution.

There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots. The reliability of positive test results is not affected.

Below is a list of the affected lots. The lot number can be found on the side of each test box along with the Use By date.
Lot Number: HB264, Use By Date: 1/1/2023, Number of Tests Shipped: 7,382
Lot Number: HY263, Use By Date: 1/1/2023, Number of Tests Shipped: 1,800
Lot Number: HY264, Use By Date: 1/1/2023, Number of Tests Shipped: 1,920

There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots. To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution. The reliability of positive test results is not affected.

Detect is notifying all customers and distributors affected by the recall. Anyone in possession of any unused tests from the affected lots should dispose of the tests. The outer packaging is recyclable while all the test components can be discarded as regular trash. Detect Hubs are not affected by the recall and do not need to be discarded.

Test users who attempt to use recalled tests will be notified in the Detect App™ that the test has been recalled and may not be used.

Detect, Inc. will issue a refund* for the affected tests (as verified by Detect) upon customers’ acknowledgement of receipt of the recall-related communication and confirmation that any affected tests in possession have been disposed of.

Company name: Detect, Inc.
Brand name: Detect
Product recalled: Over the counter Covid-19 Test
Reason of the recall: There is an increased chance that the tests from the lot numbers listed below may give false negative results
FDA Recall date: December 12, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-three-detect-covid-19-test-lots

#coronaviruscovid19 #recall #medicaldevices #us

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