Cue Health recalls specific COVID-19 test cartridges sold without FDA approval. These unapproved kits may not work correctly and could lead to inaccurate results.
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Cue Health is recalling certain COVID-19 test cartridges that were sold without FDA approval. Using these unapproved kits could result in inaccurate test results, which might lead to incorrect health decisions.
The test kits were marketed and distributed without FDA approval, meaning they haven't been tested for safety and accuracy. This could lead to incorrect test results, such as false negatives or positives, which might affect health decisions.
Home users and over-the-counter buyers of the specific test cartridges with lot numbers listed in the recall notice. People who have already purchased these cartridges are most at risk of getting inaccurate results.
Check the product label for the lot numbers listed: 30757C, 30761G, 30760C, 30884G, 30885G, and others as detailed in the recall notice. These cartridges were sold as home and over-the-counter tests.
Look for the lot numbers listed in the recall notice to confirm if your cartridge is affected.
The test kits were marketed and distributed without FDA approval, which means they haven't been tested for safety and accuracy.
Check the product label for the lot numbers listed in the recall notice to see if your cartridge is affected. If it is, you may want to stop using it to avoid inaccurate results.
The recall states these kits were sold without FDA approval, which could lead to inaccurate results, but there are no specific safety risks like injury or fire mentioned.
We’ve drafted a message you can send Cue Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0091-2025 — Cue Health Cue Health Hello, I own a Cue Health that is covered by recall Z-0091-2025 from Cue Health. 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.
