Cue Health Inc. is recalling approximately 248,109 units (56 lots) of its COVID-19 Test Cartridges used for home and over-the-counter testing. The recall was issued because these modified test kits were marketed and distributed without the necessary FDA approval, clearance, or authorization. Because these modifications were not reviewed by the FDA, the accuracy and reliability of the test results cannot be guaranteed. No specific injuries have been reported, but consumers should be aware that these tests may not perform as expected.
The use of unauthorized medical tests poses a risk of inaccurate results, including false positives or false negatives. Inaccurate results can lead to a delay in appropriate medical treatment or the unintended spread of the virus to others.
Contact healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release · Raw API Response
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