Mesa BioTech recalls Accula SARS-CoV-2 Test (REF: COV4100) due to increased false positive results, which may delay correct diagnosis and treatment. Affected units have specific model numbers listed in the recall.
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Mesa BioTech is recalling its Accula SARS-CoV-2 Test (REF: COV4100) because it has a higher chance of false positive results. This could lead to delays in getting proper diagnosis and treatment for COVID-19.
The test has an increased potential for false positive results, meaning it might show a positive result when the person does not have COVID-19. This could delay correct diagnosis and treatment, potentially leading to unnecessary isolation or missed care.
People who purchased or use the Accula SARS-CoV-2 Test (REF: COV4100) are affected. Those who rely on the test for accurate COVID-19 diagnosis are most at risk.
Check for the product code REF: COV4100 on the test kit. Affected units include specific model numbers listed in the recall notice, such as P22006-026, P22010-021, and others.
Look for the product code REF: COV4100 on the test kit and verify if it matches the listed model numbers.
The Accula SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Check for the product code REF: COV4100 on the test kit. Affected units include specific model numbers listed in the recall notice, such as P22006-026, P22010-021, and others.
The recall does not specify a remedy, so you should check the product details to confirm if it's affected and contact Mesa BioTech for further guidance.
We’ve drafted a message you can send Mesa BioTech to request your refund or repair — edit it as you like.
Subject: Recall Z-1009-2022 — Mesa BioTech Mesa BioTech Hello, I own a Mesa BioTech that is covered by recall Z-1009-2022 from Mesa BioTech. 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.
