More than 11,000 COVID-19 tests recalled due to possible false negative results
WASHINGTON (WISH) — More than 11,000 over-the-counter coronavirus tests are being recalled because they could give users false negative results, the U.S. Food and Drug Administration said Tuesday.
The tests were made by Detect, Inc., and shipped to customers nationwide between July 26 and Aug. 26, 2022.
“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,” Detect Inc. said in a statement provided by the FDA.
Detect says it has not received any reports of false negatives and is issuing the recall “out of an abundance of caution.” The company says 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 | Use By Date | # of Tests Shipped |
| HB264 | 1/1/2023 | 7,382 |
| HY263 | 1/1/2023 | 1,800 |
| HY264 | 1/1/2023 | 1,920 |
Anyone who tries to use one of the recalled tests will be notified in the DetectApp that the test has been recalled and may not be used.
Detect, Inc. will issue a refund for the affected tests only after customers have confirmed the receipt of recall-related communication and confirmation that any affected tests have been thrown out.
Customers with questions or concerns should contact Detect’s customer support team at 855-322-3692 or by email at support@detect.com.