Azure Biotech recalls specific COVID-19 IgG/IgM Rapid Test Devices with incorrect labeling and unsupported 24-month expiration dating. Affected units may not be reliable for diagnostic use.
Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
Azure Biotech is recalling certain COVID-19 rapid test devices because they have incorrect labeling and an unsupported 24-month expiration date. This could mean the tests are not reliable for diagnostic use as intended.
The tests are labeled for diagnostic use but have an unsupported 24-month expiration date. This means the tests might not work properly after the intended time frame, leading to unreliable results.
Anyone who purchased the affected test devices from the listed lot numbers. Users who rely on these tests for accurate results may be at risk of incorrect results.
Check the product label for lot numbers: I2004001, I2004003, I2006128, I2005023, or I2006030. The devices include either 'FaStep Rapid Diagnostic Test' or 'ECOTEST RAPID DIAGNOSTIC TEST' labels.
Look for lot numbers I2004001, I2004003, I2006128, I2005023, or I2006030 on the device label.
The tests have incorrect labeling and an unsupported 24-month expiration date, which could lead to unreliable results.
Check the product label for the listed lot numbers. If you have one, you may want to contact Azure Biotech for further instructions.
The recall is due to potential unreliable results, not physical safety risks. There is no immediate danger to health.
We’ve drafted a message you can send Azure Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-1432-2021 — Azure Biotech Azure Biotech Hello, I own a Azure Biotech that is covered by recall Z-1432-2021 from Azure 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.
