Detect recalls test model 21205 (HY263, HY264, HB264) due to false negatives risking missed infections and community spread. Expiration date 01JAN2023.
There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.
Detect is recalling its Covid-19 test model 21205 (HY263, HY264, HB264) because it may give false negative results. This could lead to delayed treatment and spread of COVID-19 if infected people aren't identified.
The test may show a negative result when someone is actually infected. This means infected people might not get treatment or monitor their symptoms, increasing the chance of spreading COVID-19 to others.
Anyone who purchased or uses the Detect Covid-19 test model 21205 (HY263, HY264, HB264) with expiration date 01JAN2023. People most at risk are those who rely on these tests for screening without knowing they might miss infections.
Check for the model numbers HY263, HY264, or HB264 on the test packaging. The expiration date is 01JAN2023. This product was sold by Detect Headquarters.
Look for model numbers HY263, HY264, or HB264 on the test packaging with expiration date 01JAN2023.
The recall states the test may give false negatives, but it does not say the test is dangerous if used correctly.
Check for model numbers HY263, HY264, or HB264 with expiration date 01JAN2023 on the packaging.
The recall does not specify a stop-use action; the remedy is null.
We’ve drafted a message you can send Detect to request your refund or repair — edit it as you like.
Subject: Recall Z-0879-2023 — Detect Detect Hello, I own a Detect that is covered by recall Z-0879-2023 from Detect. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
